MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP

Catalog Number 300912

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7178907, medical device expiration date: 06/30/2022, device manufacture date: 06/27/2017, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.

Event Description

It was reported that during use, a bd syringe luer-lok¿ tip malfunctioned as the plunger was reported with difficult movement.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: dhr review for batch 7178907: manufacturing dates: 7/16/2017 to 7/17/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7178907 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Investigation conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7105720
• MDR Text Key: 94523327
• Report Number: 1213809-2017-00356
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300912
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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