MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ SYRINGES WITH NEEDLES LUER SLIP TIP; SYRINGE AND NEEDLE

Catalog Number 301321

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one actual sample in open package received on 01/10/2018 and forty two representative samples were also collected for investigation.The samples were not decontaminated.The actual sample and 42 representative samples were subjected to the breakout and sustaining force test per (b)(4).Did the returned samples show the reported defect? no.Dhr review: the reviewed syringe device history record showed no quality notification was raised for the reported nonconformance.The routine silicon test passed the specifications.Manufacturing review: reviewed preventative maintenance, calibration, and equipment had no abnormality observed that could have influenced the issue.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Is the product within specification? yes.Root cause: reviewed the dhr; routine silicon test and breakout and sustaining force test passed the specifications.The 1 actual sample and 42 representative samples passed the breakout and sustain force test.Root cause could not be determined.No capa is required.

Event Description

It was reported that the plunger of the bd¿ syringe with needle luer slip tip was difficult to push.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD¿ SYRINGES WITH NEEDLES LUER SLIP TIP
• Type of Device: SYRINGE AND NEEDLE
• 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: 7210203
• MDR Text Key: 98188570
• Report Number: 8041187-2017-00302
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 301321
• Device Lot Number: 7053245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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