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

Catalog Number 300841

Device Problem Positioning Problem (3009)

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

Event Date 06/01/2018

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 during use a bd ml syringe, luer slip with needle malfunctioned as "nurse found the plunger rod tilted when opened the unit package".There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: one actual sample in open package and one representative sample were returned for investigation.Our quality engineer inspected the returned unit and could not identify any manufacturing related defects.The 1 actual sample was subject to visual inspection and no abnormality observed.The 1 actual sample and 1 representative sample were subjected to volumetric test per test procedure (b)(4) and passed the specification.Plunger rod tilted was not observed from the returned samples and the volumetric test passed the specification.A device history record review showed no non-conformance associated with this issue during the production of this batch.As a result, the root cause of the reported issue could not be determined.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that during use a bd ml syringe, luer slip with needle malfunctioned as "nurse found the plunger rod tilted when opened the unit package." there was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd ml syringe, luer slip with needle malfunctioned as "nurse found the plunger rod tilted when opened the unit package." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD ML 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: 7627552
• MDR Text Key: 112554807
• Report Number: 8041187-2018-00210
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059011
• UDI-Public: 30382903059011
• Combination Product (y/n): N
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 300841
• Device Lot Number: 7292019
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other