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

Model Number 222239

Device Problem Contamination (1120)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1152672, medical device expiration date: 2021-06-01, device manufacture date: 2021-08-26.Medical device lot #: 1154814, medical device expiration date: 2021-08-26, device manufacture date: 2021-06-01.Medical device lot #: 1131758, medical device expiration date: 2021-08-26, device manufacture date: 2021-06-01.Medical device lot #: 1099123, medical device expiration date: 2021-07-06, device manufacture date: 2021-04-09.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ 2 with contamination and 23 physical defects were observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported that there are discoloration, fill volume and cracked media.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 30-jul-2021.H.6.Investigation: during manufacturing of material 222239, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history records for batches 1152672, 1154814, 1099123 and 1131758 were satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All physical attribute and bioburden testing performed on these batches were satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is.Tested for bioburden prior to release to ensure that it conforms to product specifications.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and other complaints have been taken on batches 1152672, 1154814, 1099123 and 1131758; including other from chino hills regional reference lab.Retention samples from batches 1152672, 1154814, 1099123 and 1131758 were not available for inspection.Returns were received for investigation.Ten unopened sleeves (100 plates) from batch 1099123 were returned in a box with bubble wrap (time stamp 1417, 1424, 1441, 1501-1503, 1505).Plates were inspected and 30/100 plates had bacterial colonies growing on both media; two of these affected plates also had fungal growth observed.Affected samples were submitted to the id lab and pseudomonas fluorescens, pseudomonas fuscovaginae, serratia liquefaciens and penicillium sp.Were identified.Five photos also were received for investigation.Two photos each show the side of a sleeve from batch 1099123 with at least one plate that has microbial growth in the chromagar orientation medium.Two photos each show the bottom of a plate from batch 1099123 (time stamps 1543 and 1604) with microbial growth in the chromagar orientation medium and/or tsa with 5% sheep blood.The last photo shows the bottom of 14 plates: one plate has media splash over and the other plates have microbial colonies in one or both media.Media splash over is a filling defect were the two media of a bi-plate are mixed in at least one half of the bi-plate.This results in media appearing discolored and unevenly filled halves of the bi-plate.Nineteen photos also were received for investigation two photos each show four stacks of plates taped together with media splash over visible in the top plate of one stack.Three photos each show the side of two or three stacks of taped plates on a light bed.There are no obvious defects visible.One photo shows three stacks of taped plates with media splash over visible in the top plate.Three photos each show the bottom of a taped plate from batch 1154814 (time stamps 0823, 0930 and 1935) with media splash over.There is mixed media in one half and media that does not fill the bottom of the other half.One photo shows the top of two taped stacks of plates from batch 1154814 (time stamp 0332) with media splash over in the top plates.There is mixed media in one half and media that does not fill the bottom of the other half of each plate.One photo shows a close up of the bottom of a plate from batch 1154814 (time stamp 0840) with no obvious defects visible.Four photos each show the bottom of a taped plate from batch 1152672 (time stamps 1014, 1042, 1850 and 1852) with media splash over.There is mixed media in one half and media that does not fill the bottom of the other half.Two photos each show the bottom of a plate from batch 1152672 (time stamp 1015) with media splash over and microbial growth in one half of the bi-plate.Two photos each show the bottom of a taped plate from batch 1099123 (time stamps not readable) that is labeled as contaminated; however no microbial growth is visible in the photo.No return samples were received for investigation.Media splash over is a filling defect where the two media of a bi-plate are mixed in at least one half of the bi-plate.This results in media appearing discolored and unevenly filled halves of the bi-plate.For batch 1152672 contamination and media splash over can be confirmed from the photos provided and broken plates can be confirmed by return samples from another complaint.For batch 1154814 media splash over can be confirmed from the photos provided.Broken plates cannot be confirmed.For batch 1099123 media splash over and contamination can be confirmed by returns from another complaint.For batch 1131758 can be confirmed for media splash from photos for a previous complaint.Broken plates cannot be confirmed.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.Capa#3076308 has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.Bd will continue to trend complaints for contamination, media splash over and broken plates.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ 2 with contamination and 23 physical defects were observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " it was reported that there are discoloration, fill volume and cracked media.".

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND 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: 12310664
• MDR Text Key: 266201432
• Report Number: 1119779-2021-01360
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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