MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD ULTRA-FINE¿ SYRINGE 31G X 6MM; SYRINGE WITH NEEDLE

Catalog Number 326786

Device Problem Retraction Problem (1536)

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

Event Date 07/30/2017

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.(b)(4).

Event Description

It was reported that there was a bd ultra-fine¿ syringe 31g x 6mm with a plunger that was difficult to pull.There was no report of medical intervention or serious injury.

Manufacturer Narrative

Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review was not conducted because a lot number could not be determined.Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.

Manufacturer Narrative

Original mdr reported incorrect "date received by manufacturer".The correct date is 08/01/2017.

• Brand Name: BD ULTRA-FINE¿ SYRINGE 31G X 6MM
• 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: 6808342
• MDR Text Key: 83534799
• Report Number: 9614033-2017-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2017

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 Catalogue Number: 326786
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 07/30/2017; 08/01/2017
• Supplement Dates FDA Received: 09/22/2017; 11/14/2017
• 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