MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE WITH NEEDLE; SYRINGE AND NEEDLE

Catalog Number	309593
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 266743; medical device expiration date: 09/30/2022; device manufacture date: 09/23/2017.Medical device lot #: 7302874; medical device expiration date: 10/31/2022; device manufacture date: 10/29/2017.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 bd safety-lok¿ syringe with needles are leaking at the needle hub.Found before use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Dhr review for batch 7266743 (p/n 309593): manufacturing dates: 09/29/2017 to 10/04/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7266743 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7302874 (p/n 309593): manufacturing dates: 11/16/2017 to 11/20/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7302874 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The reviews showed no rejected inspections or quality issues during the production of the two provided lot number that could have contributed to the reported defect.Root cause and capa not required as no defects were confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SAFETY-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7492953
• Report Number: 1213809-2018-00264
• Device Sequence Number: 1313961
• Product Code: FMF
• UDI-Device Identifier: 00382903095933
• UDI-Public: 00382903095933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 309593
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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