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

Catalog Number	309581
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	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 309581 batch#: unknown it was reported that the bd luer-lok needle pulled out of the hub.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.We have received a complaint about needles that are too fragile, bend, and seem soft when piercing the stopper of a vaccine vial and on the user¿s arm.The operator tried to push on the needle with his hand, and it detached from the plastic tip.No incident reported with the user.We have a sample of the syringe with needle.¿ additional information provided: 1.Event date: 03-07-2024.2.Batch number: 3244921.3.Number of times: twice at fleury hospital and a month ago at (b)(6), representative having already been contacted a month ago.4.Address to collect sample: (b)(6).5.No incident occurred to the patient.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr/correction - needle pulled out of hub correction: following submission of initial mdr, the customer information was not correctly reported.Section e updated to reflect correct customer address.Evaluation: one sample was provided to our quality team for investigation.A visual inspection was performed with 30x magnification.The needle was broken off at the area where the epoxy that joins the needle to the needle assembly end.The top part of piece of needle left in the needle hub shows that was bent about 45 degrees.Based on the investigation and with the sample analysis the symptom reported is confirmed.It could be possible that needle got bent during the needle assembly process.Furthermore, a device history record review was completed for provided lot number 3244921.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• 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: 20092086
• Report Number: 1213809-2024-00596
• Device Sequence Number: 7810902
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: (01)30382903095811(11)230901(17)280831(10)3244921
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: Other
• Device Catalogue Number: 309581
• Device Lot Number: 3244921
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown