MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TB CARBOLFUCHSIN KF; CARBOL FUCHSIN

Model Number 212518

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while testing with bd bbl¿ tb carbolfuchsin kf precipitate and impurities were found in the stain.There was no report of patient impact.The following information was provided by the initial reporter: impurites.

Manufacturer Narrative

H6: investigation summary the complaint investigation included a review of the batch history record for tb carbolfuchsin kf.The batch history record reviews indicated no discrepancies.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints for the defect in question.Three photos were attached to the complaint submission.The first two photos depict a microscopic view with purple stain.The third photo depicts one bottle of material 212518, tb carbolfuchsin kf, lot number 1194748, expiration date 2022/07/31.The retention sample from the complaint batch was evaluated along with a control batch of tb carbolfuchsin kf.The solution appearance was satisfactory and comparable to the control; both were a reddish purple suspension with no visible precipitate, impurities or contamination.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 the retention and control batches.The retention was comparable to the control.Bd was unable to replicate the precipitate defect described by the customer.This complaint cannot be confirmed.H3 other text : see h10.

Event Description

It was reported while testing with bd bbl¿ tb carbolfuchsin kf precipitate and impurities were found in the stain.There was no report of patient impact.The following information was provided by the initial reporter: impurites.

• Brand Name: BD BBL¿ TB CARBOLFUCHSIN KF
• Type of Device: CARBOL FUCHSIN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13545001
• MDR Text Key: 288596785
• Report Number: 1119779-2022-00248
• Device Sequence Number: 1
• Product Code: ICL
• UDI-Device Identifier: 00382902125181
• UDI-Public: 00382902125181
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 212518
• Device Catalogue Number: 212518
• Device Lot Number: 1194748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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