MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML SYRINGE WITH BD BLUNT PLASTIC CANNULA

Catalog Number	303348
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 or Problem Description
It was reported that the stopper of the 10 ml syringe with bd blunt plastic cannula appears to be ¿breaking down¿ when using a particular contrast.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: sample evaluation: five sealed 10ml packaged syringes with blunt plastic cannula, and one loose assembled 10ml syringe were received by bd (b)(4) and confirmed to be from batch #7094656 (p/n 303348).A specimen cup was also received with an attached label that read 'rubber sediment in mri syringe.' the cup contained a piece of gauze with an unidentified black particle on its surface.The syringes were visually evaluated.No stopper defects were observed in the packaged syringes.The single loose 10ml syringe was in sample bag with a medicine vial.Contents were covered with medicine making visual evaluation difficult, however no stopper defects could be observed.Dhr review for batch 7094656 (p/n 303348): manufacturing dates: 04/13/2017 to 04/14/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7094656 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Bd (b)(4) was not able to duplicate or confirm the customer's indicated failure.Capa is not required as no defects were confirmed.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: 10 ML SYRINGE WITH BD BLUNT PLASTIC CANNULA
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7122833
• Report Number: 1213809-2017-00414
• Device Sequence Number: 1288123
• Product Code: FMF
• UDI-Device Identifier: 30382903033486
• UDI-Public: 30382903033486
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 03/09/2018

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: Other
• Device Catalogue Number: 303348
• Device Lot Number: 7094656
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 03/12/2018
• 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