MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number 442020

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 during use with bd bactec¿ peds plus¿/ f culture vials (plastic) a molecular false positive result was obtained for staph spp and c.Tropicalis.Confirmatory cultures were negative.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they are having molecular false positives.Patient # 1: (b)(6) 2023.Sequence #: (b)(4).Ft7473.Bcid2.Lot # 0989923, cat # rfitasy0147.Dual positive - staph spp and c.Tropicalis.Culture: coag neg staph - yeast plate still cooking.Gram stain: gpcc.Yes - don't know.

Event Description

It was reported that during use with bd bactec¿ peds plus¿/ f culture vials (plastic) a molecular false positive result was obtained for staph spp and c.Tropicalis.Confirmatory cultures were negative.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they are having molecular false positives.Patient # 1: (b)(6) 2023; sequence #: (b)(4); ft7473; bcid2; lot # 0989923, cat # rfitasy0147; dual positive - staph spp and c.Tropicalis; culture: coag neg staph - yeast plate still cooking; gram stain: gpcc; yes - don't know.

Manufacturer Narrative

The following field has been updated with corrected information: b.6.Relevant tests/laboratory data: none reported.

Manufacturer Narrative

H.6 investigation summary.Catalog: 442020.Batch no.: 3145901.Customer reported a molecular false positive result.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention/returned samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted, and batch has been previously investigated for the reported defect.Complaint is unconfirmed based on retention/returned samples and batch history record review results.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.H3 other text : see h.10.

Event Description

It was reported that during use with bd bactec¿ peds plus¿/ f culture vials (plastic) a molecular false positive result was obtained for staph spp and c.Tropicalis.Confirmatory cultures were negative.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they are having molecular false positives.Patient # 1: 9/9/23.Sequence #: 449460868106.Ft7473.Bcid2.Lot # 0989923, cat # rfitasy0147.Dual positive - staph spp and c.Tropicalis.Culture: coag neg staph - yeast plate still cooking.Gram stain: gpcc.Yes - don't know.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17865580
• MDR Text Key: 324888822
• Report Number: 2647876-2023-00219
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151866
• 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,Followup
• Report Date: 12/07/2023

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: 02/26/2024
• Device Catalogue Number: 442020
• Device Lot Number: 3145901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/31/2023; 12/07/2023
• Supplement Dates FDA Received: 11/20/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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