MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR; ENTRAL SYRINGE

Catalog Number	305853
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7281584, medical device expiration date: 2022-09-30.Device manufacture date: 2017-10-08.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 leakage occurred at the connection of a 3 ml bd¿ enteral syringe with clear barrel and bd univia¿ connector.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr review for batch 7281584 (p/n 305853): manufacturing date: 10/28/2017.Batch quantity was 112,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7281584 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.

• Brand Name: 3 ML BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR
• Common Device Name: ENTRAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7199496
• Report Number: 1213809-2017-00445
• Device Sequence Number: 16176819
• Product Code: KNT
• UDI-Device Identifier: 30382903058533
• UDI-Public: 30382903058533
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• 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): 03/15/2018

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: 305853
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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