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

Model Number 442022

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/01/2021

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.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) a broken bottle was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " according to the customer¿s report, the bottle was found to be dented.".

Manufacturer Narrative

After further review this complaint has been determined to be not reportable.The bottle was dented before use, not broken, and there was no patient sample.There would not have any impact to the patient or risk of serious injury.As a result mfr#: 2647876-2021-00132 is null and void.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) a broken bottle was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " according to the customer¿s report, the bottle was found to be dented.".

• Brand Name: BD BACTEC PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12541832
• MDR Text Key: 283771726
• Report Number: 2647876-2021-00132
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• PMA/PMN Number: K141810
• 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: 10/11/2021

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: 12/31/2021
• Device Model Number: 442022
• Device Catalogue Number: 442022
• Device Lot Number: 1076671
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1