MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305780

Device Problem Mechanical Problem (1384)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 the needle of the bd luer-lok¿ syringe with detachable bd eclipse¿ needle "got stuck twice" during use.

Manufacturer Narrative

Investigation summary: nine unused samples in sealed package were returned for evaluation.During the dhr review, there was no similar non- conformance observed during out-going inspection.For the duration of the last 12 months, there was no quality notification raised for a similar non-conformance.Investigation conclusion: the nine samples were subjected visual inspection for hooked point and damaged point.During the visual inspection, there were no abnormality observed on the 9 samples.Results of the visual inspection show that the 9 samples are within specification.Root cause description: from the samples, there was no abnormality observed during visual inspection.Rationale: if more information were received in the future the complaint will be re-opened and re-investigated.

Event Description

It was reported that the needle of the bd luer-lok¿ syringe with detachable bd eclipse¿ needle "got stuck twice" during use.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8206082
• MDR Text Key: 131907844
• Report Number: 8041187-2018-00491
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 305780
• Device Lot Number: 3260068
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other