MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 309626

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported the needle of a bd¿ tuberculin syringe with bd precision glide¿ detachable needle disconnected from the hub during a medication draw.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Two 1ml assembled syringes reported to be from batch #7211534 (p/n 309626) were depicted in the photo.The photo was visually evaluated.One syringe was missing the needle cannula.The cannula was observed to be in the medicine vial.A needle cannula which separates from the needle hub is a rejectable condition.Dhr review for batch 7211534 (p/n 309626): manufacturing dates: 07/31/2017 to 08/2/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7211534 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the sample evaluation (b)(4) was able to confirm the customer's indicated failure.Root cause and capa not required based on severity and occurrence level defined for this complaint.

• Brand Name: BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7301130
• MDR Text Key: 101174374
• Report Number: 1213809-2018-00067
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: 30382903096269
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 309626
• Device Lot Number: 7211534
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other