MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE WITH ULTRA-FINE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 326786

Device Problem Material Separation (1562)

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation summary: customer returned photos of a 1/2cc syringe.Customer states that the plunger is detached from the rubber stopper and it remains inside the barrel of the syringe.The attached photos were examined and exhibited the stopper separated from the plunger rod.A review of the device history record was completed for batch# 7352815.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure root cause description: insufficient silicone in the barrel.

Event Description

It was reported that rubber stopper on a bd syringe with ultra-fine¿ needle separated from the plunger rod.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD SYRINGE WITH ULTRA-FINE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8043375
• MDR Text Key: 128257527
• Report Number: 9614033-2018-00083
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903267866
• UDI-Public: 382903267866
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 326786
• Device Lot Number: 7352815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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