MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD SAFETY-LOK¿ SYRINGE W/ DETACHABLE NEEDLE; SYRINGE WITH HYPODERMIC NEEDLE

Catalog Number	309592
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd safety-lok syringe w/ detachable needle safety mechanism failed to engage.The following information was provided by the initial reporter: material no: 309592, batch no: unknown.It was reported that safety mechanism failed to engage and was pulled off of the syringe.I have a bd needle ref # 309592 -- the safety mechanism failed to engage and was pulled off the syringe.I don't have the original packaging, so i cannot provide a lot number, but i do have the needle.
Additional Manufacturer Narrative
Investigation: one loose 3ml syringe with a needle attached and a loose safety-lok shield was received and visually evaluated.The syringe and needle had unidentified liquid residue and could not be closely evaluated.However, no visual defects were observed on the syringe surface.The safety-lok shield was observed to not have been activated.No molding defects and no damage was observed in the shield.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Potential root cause for the safety-lok mechanism failure is likely associated with the assembly process.It is possible the shield was not properly assembled to the syringe.This product family has been discontinued and is no longer being produced.The 3ml product was discontinued from production in feb-2019.Complaints will be monitored for remaining product in the market, but no corrective actions will be taken at the manufacturing plant.
Event or Problem Description
It was reported that bd safety-lok¿ syringe w/ detachable needle safety mechanism failed to engage.The following information was provided by the initial reporter: material no: 309592 batch no: unknown.It was reported that safety mechanism failed to engage and was pulled off of the syringe.I have a bd needle ref # (b)(4) the safety mechanism failed to engage and was pulled off the syringe.I don't have the original packaging, so i cannot provide a lot number, but i do have the needle.

• Brand Name: BD SAFETY-LOK¿ SYRINGE W/ DETACHABLE NEEDLE
• Common Device Name: SYRINGE WITH HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8603777
• Report Number: 1213809-2019-00525
• Device Sequence Number: 2075195
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: 30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• 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): 06/11/2019

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: 309592
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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