MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309594
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
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: 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.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use of the bd safety-lok¿ syringe they found 6 empty blister packs and 2 sealed packages where the needle was separated and rolling around freely.
Event or Problem Description
It was reported that during use of the bd safety-lok¿ syringe they found 6 empty blister packs and 2 sealed packages where the needle was separated and rolling around freely.
Additional Manufacturer Narrative
Investigation: eight fully sealed blister packs confirmed to be from batch #8307689 (p/n 309594) were received and evaluated.It was observed six of the packages were empty and two of the packages contained 3ml syringes with needles with no evidence of manipulation.In the blister packs with syringes it appeared all components were present, but the hub was detached from the syringe.Furthermore, 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 no root cause as defect was not confirmed.

• Brand Name: BD SAFETY-LOK¿ SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8401354
• Report Number: 1213809-2019-00309
• Device Sequence Number: 2054068
• Product Code: FMI
• UDI-Device Identifier: 30382903095941
• UDI-Public: 30382903095941
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: Health Professional
• Device Catalogue Number: 309594
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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