MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221742

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that prior to use, bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin tubes were contaminated.The following information was provided by the initial reporter: it was reported by the customer that there is contamination on media 221742 with lot#: 1238117 right out of the box.

Manufacturer Narrative

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

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 prior to use, bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin tubes were contaminated.The following information was provided by the initial reporter: it was reported by the customer that there is contamination on media 221742 with lot#: 1238117 right out of the box.

Manufacturer Narrative

H.6 investigation summary complaint investigation material 221742 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 1238117 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torqueing, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and one other complaint has been taken on this batch for contamination.Retention samples from batch 1238117 (10 tubes) were available for inspection.All 10/10 retention tubes did have a hazy appearance.For investigation two retention tubes went investigation.One retention tube went into 20¿25-degree celsius incubation.One retention tube went into 33-37-degree celsius.At the end of a seven-day incubation period the media still appeared hazy in appearance.A gram stain was performed no viable organisms were found.Four photos were received to assist with the investigation: the first photo shows two tubes from batch 1238117.The media does appear to have a hazy appearance.The second photo also shows two tubes from batch 1238117.The media does appear to have a hazy appearance.The third photo shows the label from one side of a partial carton from batch 1238117 carton number 0023.The last photo shows three tubes, the media does appear to be hazy in one of the tubes.For appearance of the media, material 221742 procedure states to boil the tubes with loosened caps for ten minutes before use.For investigation purpose three return tubes and one retention tube were boiled for approximately ten minutes per procedure; the media appearance cleared to a light/medium light yellow clear appearance as describe in the certificate of analysis.Returns were also received to assist with the investigation.A shipping box was received with four bd cartons from batch 1238117 carton numbers 0023, 0027, 0030, and 0018.There were 346 tubes received in overall good condition.The media did appear hazy.For investigation of complaint all four cartons went into incubation.One tube was plated on two tsa 5% sheep blood agar.One plate was placed in the 20-25-degrees celsius incubation and one plate was placed in 33-37-degree celsius incubation.There was no microbial growth on either plate after incubation.Two cartons were placed into 20-25-degrees celsius incubation.Two cartons were placed into 33-37-degrees celsius incubation.At the end of a seven-day incubation period there was no real change in the media after incubation.A gram stain was performed on one tube from batch 1238117, the gram stain revealed gram negative rods.This complaint can be confirmed for non-viables from the returns received.A trend has not been identified, therefore, there are no actions planned at this time.Bd will continue to trend complaints for non-viables.Notes risk management review indicates the potential risk of the defect reported was assessed as severity s1, per [baltrmterminalgpaph ], rev 04 id 18.0 see h.10.

Event Description

It was reported that prior to use, bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin tubes were contaminated.The following information was provided by the initial reporter: it was reported by the customer that there is contamination on media 221742 with lot#: 1238117 right out of the box.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13012314
• MDR Text Key: 285747664
• Report Number: 1119779-2021-01965
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217429
• UDI-Public: 30382902217429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803023
• 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: 06/30/2022

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: 08/20/2022
• Device Model Number: 221742
• Device Catalogue Number: 221742
• Device Lot Number: 1238117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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