MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN; PISTON SYRINGE

Catalog Number	309581
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle 25 g x 1 in.Have broken.The following information was provided by the initial reporter: the customer states that these items have a defect and have broken off in the arms of patients spilling approximately $200 worth of vaccine on the ground.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 309581 and lot number 2181981.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle 25 g x 1 in.Have broken.The following information was provided by the initial reporter: the customer states that these items have a defect and have broken off in the arms of patients spilling approximately $200 worth of vaccine on the ground.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15921009
• Report Number: 1213809-2022-01162
• Device Sequence Number: 2492663
• Product Code: FMF
• UDI-Device Identifier: 50382903095815
• UDI-Public: 00382903095810
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309581
• Device Lot Number: 2181981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown