MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TB POTASSIUM PERMANGANATE; STAINS, MICROBIOLOGIC

Model Number	212513
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
It was reported that while using bd bbl¿ tb potassium permanganate contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-04-05 h6: investigation summary the complaint investigation included a review of the batch history record of tb potassium permanganate.The batch history record review indicated no discrepancies.All release testing was satisfactory.Satisfactory appearance for tb potassium permanganate is purple solution.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints on this batch.Three photos were received along with this complaint.Two of the photos depict two bottles of potassium permanganate 212513, lot number 0267715, and expiration date 2021/10/31.The third photo depicts three glass slides covered with a range of purple-colored solutions.The right slide is labeled as ¿acceptable colour¿, the middle slide states ¿change in colour,¿ and the left slide is labeled ¿become lighter¿.Returns (two bottles of the same lot) were received on 04/05/21.The returns (both bottles) and a retention sample from the complaint batch were evaluated along with a control batch.The solution appearance of the return samples was not satisfactory and not comparable to the retention sample and control.One bottle of return was light purple before shaking the bottle and became a brown-purple color with brown precipitate after shaking the bottle.The second bottle was purple with slight precipitate before shaking the bottle and became brown-purple with brown precipitate after shaking the bottle.The solution appearance of the retention sample was satisfactory and comparable to the control; both were a purple solution without precipitate.Staining was completed per instructions in the product insert.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results with one of the return bottles, retention, and control batches.The return and retention sample were comparable to the control.The second bottle of return (with lighter color of solution) gave unsatisfactory staining result compare to retention and control samples.The background of the return was atypical compare to control and retention samples and had light greenish hazy spots.This complaint has been confirmed.Root cause for the color variability and precipitate observed in the customer returns remains unknown.This complaint is the only known incident of this defect for this lot, and appears to be an isolated incident.No corrective actions are slated at this time.See h10.
Event or Problem Description
It was reported that while using bd bbl¿ tb potassium permanganate contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD BBL TB POTASSIUM PERMANGANATE
• Common Device Name: STAINS, MICROBIOLOGIC
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11547979
• Report Number: 1119779-2021-00537
• Device Sequence Number: 19856532
• Product Code: JTS
• UDI-Device Identifier: 00382902125136
• UDI-Public: 00382902125136
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 212513
• Device Catalogue Number: 212513
• Device Lot Number: 0267715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1