MAUDE Adverse Event Report: BD CARIBE, LTD BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); MICROBIAL GROWTH MONITOR

Catalog Number 442023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that after processing a bd bactec¿ plus aerobic/f culture vials (plastic) that had been flagged as positive, a lab technician received a dirty needle stick injury from a needle of unknown origin.The tech was disposing of the needle and it bounced out of the sharps container and punctured tech's hand.

Manufacturer Narrative

Customer reported a needle stick injury during sample processing.Tech was disposing the needle and it bounced out of the sharps container and punctured tech's hand.Bd cayey was not able to perform an investigation since the event is not related to the bactec bottle.This is a needle handling issue which was not affected by the bactec bottle.Dhr could not be performed as the lot number is unknown.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.No root cause was determined.

Event Description

It was reported that after processing a bd bactec plus aerobic/f culture vials (plastic) that had been flagged as positive, a lab technician received a dirty needle stick injury from a needle of unknown origin.The tech was disposing of the needle and it bounced out of the sharps container and punctured tech's hand.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: MICROBIAL GROWTH MONITOR
• Manufacturer (Section D): BD CARIBE, LTD; vicks drive; lot no. 1; cayey
• MDR Report Key: 8010341
• MDR Text Key: 125185079
• Report Number: 2647876-2018-00023
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 442023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention