MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221716

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 5 un-inoculated tubes of bd bbl¿ trypticase¿ soy broth were smeared and have bacillus growth in them.The following information was provided by the initial reporter: it was reported that reported that a couple of un-inoculated tubes were smeared and they have bacillus growing in them (b)(4) ¿is the lot number of the contaminated media 1070131? yes ¿upon receiving: who is the distributor and what temperature were the media shipped? cardinal health and refrigerated.¿ if at later time: what was the storage temperature of media? were sleeves sealed during storage? storage temperature was refrigerated.These are broth tubes and they come in a box.¿ any recent temperature excursions? no ¿ was contamination noticed before or after inoculation? after inoculation ¿ if after inoculation, were any patient results reported? no ¿ bacteria or fungi contamination ¿ colony color? bacteria (gram positive rods, most likely bacillus species) we did not subculture them to plates.¿ were the organism gram stained or identified? broth was gram stained.¿approximate quantity of product received in shipment? unsure ¿approximate number of media contaminated? 12 were inoculated that were all positive.We gram stained 3 of the un-inoculated ones that also had gram positive rods in the smear.We have another box of 100 of the same lot that look cloudy now.¿are you able to please provide photos of the media with contamination capturing the catalog number and the lot number? yes, please see attached ¿ are the uninoculated products available to return?? yes, if you want them back.Please provide shipping labels.¿are you requesting for a replacement? we placed a new order on wednesday 6/2 on po# (b)(4) but the same lot was shipped.We received 3 boxes of 100 each of the same lot.They do not look cloudy, however, we will not be using them due to the potential for contamination.(b)(4) ¿ customer problem: customer had an issue with lot number 1070131 (exp 9/7/2022) of the bd trypticase soy broth.We had multiple cultures inoculated where the plated media was sterile, however, all of the tsbs were positive.We smeared these tubes and they all have bacillus growing in them.We also smeared a couple of un-inoculated tubes and they also have bacillus growing in them.We placed a new order for a different lot of tsbs today.I am unsure if anyone else has brought this to your attention so i wanted to make sure that you were aware.¿ if media performance issue provide organism atcc strain information (if applicable): n/a ¿ steps taken with customer/troubleshooting: pending additional information ¿ next steps (if necessary):pending additional information ¿ resolution achieved (y/n)? : n ¿ quantity received and quantity affected: pending additional information ¿ shipment method (directly or via distributor): pending additional information ¿ if it is a distributor or directly from bd ¿ who is it?: pending additional information ¿ photos or returns requested? : pending additional information ¿ follow up required y/n?: y ¿ if consumable is tested on bd instrumentation, list serial numbers: n/a ¿ time stamp (if applicable): n/a ¿ indication that customer is industrial indu (if applicable): n ¿ reviewed smax case history: y ¿ help lightning attempt: no help lightning success: n/a (b)(4).Reported that a couple of un-inoculated tubes were smeared and they have bacillus growing in them.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-09.H6: investigation summary: material 221716 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 1070131 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and torquing processes were within specifications.Qc inspection and testing was satisfactory at time of release.Direct staining techniques are not part of qc release testing for this product.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and two other complaints have been taken on this batch for contamination.Retention samples from batch 1070131 (10 tubes) were available for inspection.No cap, tube or media defects were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of light to medium light yellow, trace hazy to clear.For further investigation, two retention tubes from batch 1070131 were tested for appearance.One retention tube was incubated at 20-25 degrees celsius, and another retention tube was placed in the 33-37 degrees celsius incubator.At 7 days incubation, there was no microbial growth or turbidity in either retention tube.Three photos were received to assist with the investigation: the first photo show tubes in a tube rack in an open box.The focus was on the media from one tube from batch 1070131.The appearance of the media does appear turbid.The second photo shows tubes in a tube rack in a open bd carton from batch 1070131.The third photo shows an open bd carton with tubes in the carton.The media of the tubes in this photo cannot be seen.This photo focuses on the bd carton label from batch 1070131, carton number 0020.Returns were received for the investigation.Three tubes from batch 1070131 in one were returned in a bubble wrapped envelope.All three tubes were received in good condition.All three tubes were received with a hazy appearance.One non-incubated return tube was gram stained.The gram stain showed gram variable rods.For further investigation, two return samples from batch 1070131 were incubated.One return tube was placed in the 20-25 degree c incubator.One return tube was placed in the 33-37 degree c incubator.At 7 days incubation, the tubes still had a trace hazy appearance.One incubated return tube was gram stained.The gram stain also showed gram variable rods.This complaint can be confirmed from the photos and the returns for non-viables.A trend has not been identified, therefore, there are no actions planned at this time.Bd will continue to trend complaints for contamination and non-viables.

Event Description

It was reported that 5 un-inoculated tubes of bd bbl¿ trypticase¿ soy broth were smeared and have bacillus growth in them.The following information was provided by the initial reporter: it was reported that reported that a couple of un-inoculated tubes were smeared and they have bacillus growing in them roberta alalade : 2021-06-07 19:31:55 (gmt) ¿is the lot number of the contaminated media 1070131? yes ¿upon receiving: who is the distributor and what temperature were the media shipped? cardinal health and refrigerated.If at later time: what was the storage temperature of media? were sleeves sealed during storage? storage temperature was refrigerated.These are broth tubes and they come in a box.Any recent temperature excursions? no was contamination noticed before or after inoculation? after inoculation if after inoculation, were any patient results reported? no bacteria or fungi contamination ¿ colony color? bacteria (gram positive rods, most likely bacillus species) we did not subculture them to plates.Were the organism gram stained or identified? broth was gram stained.Approximate quantity of product received in shipment? unsure.Approximate number of media contaminated? 12 were inoculated that were all positive.We gram stained 3 of the un-inoculated ones that also had gram positive rods in the smear.We have another box of 100 of the same lot that look cloudy now.Are you able to please provide photos of the media with contamination capturing the catalog number and the lot number? yes, please see attached.Are the uninoculated products available to return?? yes, if you want them back.Please provide shipping labels.Are you requesting for a replacement? we placed a new order on wednesday 6/2 on po# 2001030702 but the same lot was shipped.We received 3 boxes of 100 each of the same lot.They do not look cloudy, however, we will not be using them due to the potential for contamination.(b)(4) : (b)(6) 2021, 14:29:51 (gmt), subject: email 6/7/2021, 8:33:37 am, user: (b)(6), created on: 2021-06-07 12:33:37, call activity comment: null.(b)(4) : (b)(6) 2021,19:18:34 (gmt).Customer problem: customer had an issue with lot number 1070131 (exp 9/7/2022) of the bd trypticase soy broth.We had multiple cultures inoculated where the plated media was sterile, however, all of the tsbs were positive.We smeared these tubes and they all have bacillus growing in them.We also smeared a couple of un-inoculated tubes and they also have bacillus growing in them.We placed a new order for a different lot of tsbs today.I am unsure if anyone else has brought this to your attention so i wanted to make sure that you were aware.If media performance issue provide organism atcc strain information (if applicable): n/a.Steps taken with customer/troubleshooting: pending additional information next steps (if necessary): pending additional information.Resolution achieved (y/n)? : n.Quantity received and quantity affected: pending additional information.Shipment method (directly or via distributor): pending additional information.If it is a distributor or directly from bd ¿ who is it?: pending additional information.Photos or returns requested? : pending additional information.Follow up required y/n?: y.If consumable is tested on bd instrumentation, list serial numbers: n/a.Time stamp (if applicable): n/a.Indication that customer is industrial indu (if applicable): n.Reviewed smax case history: y.Help lightning attempt: no.Help lightning success: n/a.(b)(4) : (b)(6) 2021, 18:21:27 (gmt) reported that a couple of un-inoculated tubes were smeared and they have bacillus growing in them.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12088363
• MDR Text Key: 281607660
• Report Number: 1119779-2021-01084
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/07/2022
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 1070131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1