MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; TUBERCULIN SYRINGE AND NEEDLE

Catalog Number 309626

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 a consumer and her husband had difficulty removing the needle shield of a 1 ml bd¿ tuberculin syringe with 25 g x 5/8 in.Bd precisionglide¿ detachable needle and the consumer's husband suffered a needle stick injury.There was no report of medical intervention.

Manufacturer Narrative

Investigation summary: dhr review for batch 6209600 (p/n (b)(4)): manufacturing dates: 08/07/2016 ¿ 8/08/2016.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6209600 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: five loose 1ml s/t assembled syringes with needles were received by bd canaan and reported to be from batch #6209600 (p/n (b)(4)).The samples were visually evaluated.No visual defects observed.Shield removal testing was performed on all 5 samples.All results were within specified range 0.5 lbs ¿ 5.5lbs per product specification.Refer to results below.Sample 1 - 3.35 lbs, sample 2 - 3.13 lbs, sample 3 - 1.84 lbs, sample 4 - 2.82lbs, sample 5 - 2.78lbs.Based on the sample evaluation: unconfirmed: bd (b)(4) was not able to duplicate or confirm the customer's indicated failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.

• Brand Name: 1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: TUBERCULIN SYRINGE AND NEEDLE
• 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: 6697725
• MDR Text Key: 79928497
• Report Number: 1213809-2017-00037
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 309626
• Device Lot Number: 6209600
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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