MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK¿ SYRINGE, LUER-LOK¿; HYPODERMIC SYRINGE

Catalog Number 302149

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's phone#: (b)(6).Investigation: no photos and samples were returned for investigation.Root cause could not be determined.If samples are received in the future the complaint will be re-opened and re-investigated.Reviewed the dhr and leak test passed the outgoing inspection.No photos and samples were returned for investigation.Root cause could not be determined.If samples are received in the future the complaint will be re-opened and re-investigated.

Event Description

It was reported during use of the bd plastipak¿ syringe, luer-lok¿ the syringe was used for drawing up two different medications in the same syringe.It was then capped with a yellow syringe cap.Upon inspection all six syringes were leaking through to the black rubber plunger.As a result the drugs needed to be disposed of.There was no report of injury or medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE, LUER-LOK¿
• Type of Device: HYPODERMIC 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 ; 8015652845
• MDR Report Key: 7155210
• MDR Text Key: 96238299
• Report Number: 8041187-2017-00269
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 302149
• Device Lot Number: 6326023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• 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