MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE 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 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: fmi.Medical device type: hypodermic single lumen needle.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k941562.Pma / 510(k)#: k161170.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 bd eclipse¿ bd luer-lok¿ syringe with detachable needle stopper separated from the plunger upon retraction during use, getting stuck and preventing medication from being drawn up into the vial.The following information was provided by the initial reporter: "the black rubber tip that is connected to the white pushing device comes apart in the syringe once retracted.The rubber tip gets stuck inside the syringe, so medication cannot be drawn up from vial.".

Manufacturer Narrative

Investigation: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause could be determined and complaint could not be confirmed.

Event Description

It was reported that the bd eclipse¿ bd luer-lok¿ syringe with detachable needle stopper separated from the plunger upon retraction during use, getting stuck and preventing medication from being drawn up into the vial.The following information was provided by the initial reporter: "the black rubber tip that is connected to the white pushing device comes apart in the syringe once retracted.The rubber tip gets stuck inside the syringe, so medication cannot be drawn up from vial.".

• Brand Name: BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8610064
• MDR Text Key: 145113852
• Report Number: 8041187-2019-00371
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other