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

Catalog Number 302149

Device Problems Connection Problem (2900); Material Deformation (2976)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 2 of the bd plastipak¿ luer-lok¿ syringes wouldn't connect to the needleless injection port during use due to what appeared to be "extra plastic" in the luer.As reported by the customer, "customer in field tried to connect the syringe to the needle free injection port but was unable to as the luer of the syringe appeared to have extra plastic which didn't allow the product to connect.".

Manufacturer Narrative

Investigation summary: the complaint is unconfirmed as no photo and no samples for received.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 and no photos displaying the reported condition were received no defects can be confirmed.

Event Description

It was reported that 2 of the bd plastipak¿ luer-lok¿ syringes wouldn't connect to the needleless injection port during use due to what appeared to be "extra plastic" in the luer.As reported by the customer, "customer in field tried to connect the syringe to the needle free injection port but was unable to as the luer of the syringe appeared to have extra plastic which didn't allow the product to connect.".

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8391380
• MDR Text Key: 138237799
• Report Number: 8041187-2019-00190
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 302149
• Device Lot Number: 8239381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other