MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309631
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd luer-lok needle pulled out of the hub.The following information was provided by the initial reporter: the needle is detached from the plastic hub as will be shown in the photo attached in the email.When did the incident occur? before use.
Additional Manufacturer Narrative
Investigation results: one photo was provided to our quality team for evaluation.The photo shows a syringe with the bottom part of the needle hub assembled to it.The top part of the needle hub is with the plastic shield.No defect or imperfection was observed; therefore, the incident could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Since a physical sample was not provided and no defects could be seen in the photo provided, a root cause could not be established.
Event or Problem Description
No additional information.

• Brand Name: BD LUER-LOK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19430989
• Report Number: 1213809-2024-00332
• Device Sequence Number: 8047774
• Product Code: FMF
• UDI-Device Identifier: 30382903096313
• UDI-Public: (01)30382903096313(11)211001(17)260930(10)1274090
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 309631
• Device Lot Number: 1274090
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown