MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL MIDDLEBROOK ADC ENRICHMENT; SUPPLEMENT, CULTURE MEDIA

Catalog Number 211887

Device Problem Unable to Obtain Readings (1516)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter: address unavailable.(b)(6).

Event Description

It was reported that while using bd bbl" middlebrook adc enrichment atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it seems that something was wrong with lot number 0051664 (211887).Bacteria did not grow at their normal rate when adding this supplement.The performance was not the expected one and the customer claims that they have spent much time and several other items, which they had to throw away due to the bad results they got.".

Manufacturer Narrative

Investigation: material 211887 is manufactured by rehydrating the media components with usp purified water, thoroughly mixing until a homogeneous solution is obtained, and the solution is then sterile filtered.Tubes are filled, capped and torqued per standard operating procedures (sop).Tubes are then sent to a separate packaging area for labeling and to be packed into final shipping configurations.The batch history record reviews for batch 9346056 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation , filling and torquing processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed for batch 9346056 and one other complaint has been taken on each batch for performance (but are also not confirmed).Retention samples from batch 9346056 were not available for visual inspection.It is noted that this complaint was taken on march 15, 2021.Batch 9346056 expired on 2020-08-04.Bd makes no claims on expired products.Retention samples could not be tested for this investigation.No photos or returns were received from the customer.The complaint cannot be confirmed.

Event Description

It was reported that while using bd bbl¿ middlebrook adc enrichment atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it seems that something was wrong with lot number 0051664 (211887).Bacteria did not grow at their normal rate when adding this supplement.The performance was not the expected one and the customer claims that they have spent much time and several other items, which they had to throw away due to the bad results they got.".

• Brand Name: BD BBL MIDDLEBROOK ADC ENRICHMENT
• Type of Device: SUPPLEMENT, CULTURE MEDIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11642330
• MDR Text Key: 274264578
• Report Number: 1119779-2021-00633
• Device Sequence Number: 1
• Product Code: JSK
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/04/2020
• Device Catalogue Number: 211887
• Device Lot Number: 9346056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1