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

Model Number 221093

Device Problem Inaccurate Information (4051)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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¿ trypticase¿ soy broth incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " customer problem: customer reporting lot number on tube labels doesn¿t match lot number on packaging labels for product 221093".

Manufacturer Narrative

H.6.Investigation: material 221093 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 0245498 was satisfactory per internal procedures.Formulation, filling and labeling processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 0245498 (10 tubes) were available for inspection.No labeling defects were observed in 10/10 retention samples.The labeling process for material 221093 includes label reconciliation where the total number of labels issued is reconciled with the total quantity of labels applied to tubes, affixed to the batch history record, rejected and unused.Any discrepancies must be within allowable limits specified in the labeling control procedure.The label reconciliation for batch 0245498 shows there was not a shortage or excess of labels after the manufacturing.Two photos were received to assist with the investigation: the first photo shows a packaging label on a shipping box.The second photo shows a tube from batch 0245498.Also noted is a shipping receipt for batch 0294209.No other observations can be made from the photos.The product is not mislabeled, either the wrong shipping receipt or product was received with the order.No returns were received to assist with the investigation.The complaint cannot be confirmed by the photos provided.Bd will continue to trend complaints for labeling.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " customer problem: customer reporting lot number on tube labels doesn¿t match lot number on packaging labels for product 221093".

• 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: 12025739
• MDR Text Key: 269596078
• Report Number: 1119779-2021-01004
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902210932
• UDI-Public: 30382902210932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 10/25/2021

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: 03/02/2022
• Device Model Number: 221093
• Device Catalogue Number: 221093
• Device Lot Number: 0245498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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