MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE WITH INTERLINK® VIAL ACCESS; HYPODERMIC SYRINGE W/ 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: unknown.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" syringes with interlink¿ vial access are breaking in vials.Two nurses received scratches from the broken tips.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
One stapled closed 3ml packaged syringe was received by bd canaan and confirmed to be from batch #7269839 (p/n 303401).The sample was visually evaluated.The syringe was found to have the vial access cannula tip broken at the narrow section of the hub.Dhr review for batch 7269839 (p/n 303401): manufacturing dates: 10/02/2017 to 10/03/2017.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 7269839 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.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.Confirmed: bd (b)(4)was able to confirm the customer's indicated failure.Root cause undetermined.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: BD¿ SYRINGE WITH INTERLINK® VIAL ACCESS
• Common Device Name: HYPODERMIC SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7131984
• Report Number: 1213809-2017-00379
• Device Sequence Number: 10779977
• 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): 02/20/2018

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: 7163859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/21/2018
• 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