MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP

Catalog Number 302995

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 a "faulty" bd syringe luer-lok¿ tip which "exploded" during a drug infusion.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Investigation conclusion: bd was not able to confirm the customer¿s indicated failures.No root cause can be determined as no samples were received.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7599249
• MDR Text Key: 111449074
• Report Number: 1213809-2018-00364
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302995
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other