MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER LOCK SYRINGE

Catalog Number 302135

Device Problem Difficult to Remove (1528)

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

Event Date 04/03/2019

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 there were 3 occurrences where the plunger was difficult to withdraw with a bd luer lock¿ syringe.The following information was provided by the initial reporter: the plunger is quite firm when trying to aspirate.There is a need to increase pressure on the plunger to withdraw the plunger.

Manufacturer Narrative

Investigation: photo evaluation: one photo was returned for evaluation.The photo sample shown material from batch 8239344 and no abnormality found on syringe product.3 samples were returned for evaluation.All 3 samples were subjected to plunger breakout and sustaining force test per test procedure 80005457.Result showed breakout and sustaining force is within the product specification the complaint is unconfirmed, and product is within specification.Review the dhr and no abnormality detected during production.The actual sample and representative sample passed the plunger breakout force and sustaining force test specification.Hence root cause could not be determine.

Event Description

It was reported that there were 3 occurrences where the plunger was difficult to withdraw with a bd luer lock¿ syringe.The following information was provided by the initial reporter: the plunger is quite firm when trying to aspirate.There is a need to increase pressure on the plunger to withdraw the plunger.

• Brand Name: BD LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8535620
• MDR Text Key: 145115966
• Report Number: 8041187-2019-00313
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 302135
• Device Lot Number: 6328399
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other