MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS; HYPODERMIC SYRINGE WITH NEEDLE

Catalog Number	303405
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the tips on bd" 10 ml syringes with interlink¿ vial access broke in vials.Two nurses received scratches from the broken tips.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: one stapled closed 10ml packaged syringe was received by bd canaan and confirmed to be from batch #7163869 (p/n 303405).The sample was visually evaluated.The syringe was found to have the vial access cannula tip broken off at the narrow section of the hub.A device history record (dhr) review for batch 7163869 (p/n 303405) was performed, manufacturing date: 07/09/2017, batch quantity was (b)(4).Assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7163869 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Although the defect of tip breakage was observed, since no physical evidence was found to support manufacturing process related issues, a root cause could not be determined.Based on the sample evaluation: confirmed: bd canaan was able to confirm the customer's indicated failure.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.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.

• Brand Name: BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS
• Common Device Name: HYPODERMIC SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7122577
• Report Number: 1213809-2017-00380
• Device Sequence Number: 11095725
• Product Code: FMI
• UDI-Device Identifier: 30382903034056
• UDI-Public: 30382903034056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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
• Operator of Device: Nurse
• Device Catalogue Number: 303405
• Device Lot Number: 7163869
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other