MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number 309626

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the 1 ml bd" tuberculin syringe with bd precisionglide" detachable needle was missing the scale marking completely.Found before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Dhr review for batch 7087644 (p/n 309626): manufacturing dates: 04/01/2017 to 04/05/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.An oven chain adjustment was recorded performed at the marker.Batch 7087644 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Five 1ml sealed packaged syringes and two loose 1ml assembled syringes with clear liquid residue inside were received by bd (b)(4) and confirmed to be from batch #7087644 (p/n 309626).The samples were visually evaluated.All 7 samples were found to have no print on the barrels.One of the loose syringes was found to have a scuff mark approximately ¿ inch wide circling around the barrel about 1/3 of the way down from the tip.Based on the investigation results to date, it is possible there was a timing issue at the marker, which involved the oven chain.If barrels delivered to the printing pad were out of time with the marked image on the pad then it is possible for the barrels to not receive any marking or partial markings.It is possible a limited number of affected barrels escaped detection and became mixed in with good product.Conclusion: bd was able to confirm the customers indicated failure.Corrective actions: adjustments were recorded performed at the time the issue was observed during production.Aql at bd (b)(4) for missing print is 0.25%.To date, 7 samples have been confirmed with missing print from batch 7087644.Defective rate identified =(b)(4), which is well within the established aql.Current controls in place include periodic product/component inspections at all stages of manufacturing.No additional actions are recommended at this time.

• Brand Name: 1 ML BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: PISTON 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: 7060558
• MDR Text Key: 93479721
• Report Number: 1213809-2017-00264
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096268
• UDI-Public: 00382903096268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 309626
• Device Lot Number: 7087644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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