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

Catalog Number 305780

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device type: fmi/fmf.(b)(6).Pma / 510(k)#: k941562 (syringe); k161170 (needle).Investigation summary: the complaint is unconfirmed as no photo / samples received.Dhr review was performed.The batgch was built with combo packaging machine in august 2018.There were no damage/distorted barrel reject at the outgoing inspection.No quality notification was raised for past 12 months on similar reported defects.Root cause description: 1ml syringe is supplied by bd cannan and not manufactured in tuas.The packaging line was reviewed and there is no process which could have caused stopper separation from plunger.Bd cannan had been notified of this complaint.

Event Description

It was reported that the stopper separates from plunger with a bd eclipse¿ bd luer-lok¿ syringe with detachable needle.The following information was provided by the initial reporter: material no: 305780, batch no: 8207169.It was reported that the rubber stopper comes apart from the plunger.Description: the black rubber tip on the white pusher inside the syringe, comes apart, and rubber piece gets stuck once retracted, inside the syringe.Unable to draw up medication.

• Brand Name: BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8601293
• MDR Text Key: 145114483
• Report Number: 8041187-2019-00364
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305780
• Device Lot Number: 8207169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other