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	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ 10 ml syringe with interlink® vial access contained foreign matter.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: one opened blisterpack containing a 10ml syringe with needle attached was received in an envelope.The package was confirmed to be from batch #8010900 (p/n 303405).Stopper was observed to have a large piece of foreign matter attached to the top, in the fluid path.The foreign matter appeared to be a large piece of tape, larger than level 3 in size.Potential root cause for the foreign matter defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that bd¿ 10 ml syringe with interlink® vial access contained foreign matter.No serious injury or medical intervention was reported.

• 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: 7986812
• Report Number: 1213809-2018-00679
• Device Sequence Number: 19146170
• Product Code: FMI
• UDI-Device Identifier: 30382903034056
• UDI-Public: 30382903034056
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 303405
• Device Lot Number: 8010900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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