MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ SYRINGE, LUER SLIP WITH NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 300841

Device Problems Material Protrusion/Extrusion (2979); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 11/22/2018

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 with the use of the bd¿ syringe, luer slip with needle there was an issue with needle through shield before use.

Manufacturer Narrative

Investigation summary: one photo was received for investigation and observed cannula pierce through the needle shield.Dhr review of the manufacturing process showed no quality notification was raised for similar nonconformance in the last 12 months.No similar defect was found during qa outgoing inspection on the batch or the component assembly batches.Investigation conclusion: this incident could have occurred during the shield insertion station at needle assembly manufacturing process.The misalignment of shield manifold may have resulted in the shield hitting the needle tip and pierce through shield when it is loaded onto the hub.There is hourly in process inspection for the defect and outgoing quality inspection.There is a vision system before the shielding station that checks and rejects those cannulas that do not allow light to pass through.There is no vision system after the shield station due to difficultly to see through the shield.After the shield station, only parts without shield will be rejected.Root cause description: probable root cause can be correlated with machines.Rationale: no capa is required.The defect trend will continue to be monitored.

Event Description

It was reported with the use of the bd¿ syringe, luer slip with needle there was an issue with needle through shield before use.

• Brand Name: BD¿ SYRINGE, LUER SLIP WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8142364
• MDR Text Key: 129785666
• Report Number: 8041187-2018-00455
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 300841
• Device Lot Number: 8109326
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other