MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H10; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 222239

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

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1057953.Medical device expiration date: 2021-05-28.Device manufacture date: 2021-02-26.Medical device lot #: 1063384.Medical device expiration date: 2021-05-31.Device manufacture date: 2021-03-04.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 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ had 20 plates of each lot that had "moldy" contamination.The following information was provided by the initial reporter: moldy, pollution.

Manufacturer Narrative

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 1057953, 1063384 and 1085486 were satisfactory and no quality notifications were generated during manufacturing and inspection of these batches.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All bioburden testing performed on these batches was 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 no other complaints have been taken on batch 1063384 for contamination.Other complaints for contamination have been taken on batches 1057953 and 1085486.Retention samples for batches 1057953, 1063384 and 1085486 were not available for inspection.Two photos were received for investigation.One photo shows the bottom of several plates from batch 1063384 and 1085486; only one plate from batch 1085486 (time stamp not readable) has a microbial colony in the tsa with 5% sheep blood agar.The other photo shows the agar surface of five opened bi-plates from batches 1057953 (time stamp 2002) and 1085486 (time stamps not readable) with bacterial colonies growing on at least one of the media.No return samples were received for investigation.This complaint can be confirmed.Due to the number of complaints taken for contamination for material 222239, capa#3076308 has been initiated to determine the root cause and corrective actions of the contamination.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

Event Description

It was reported that bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ had 20 plates of each lot that had "moldy" contamination.The following information was provided by the initial reporter: moldy, pollution.

• Brand Name: SEE H10
• 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: 12434457
• MDR Text Key: 275492293
• Report Number: 1119779-2021-01476
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902222399
• UDI-Public: 10382902222399
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/24/2021
• Device Model Number: 222239
• Device Catalogue Number: 222239
• Device Lot Number: 1085486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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