MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LS SP125; PISTON SYRINGE

Catalog Number	309647
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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#:309647, batch#: unknown.It was reported that the bd syringe 5ml ls sp125 stopper was defective / damaged.The following information was provided by the initial reporter: something with the rubber.I don't have the full explanation of the issue.I also don't have a lot number.Additional information provided: please provide the date of event: aug 26, 2024.2.Please share the captured photo of the event if available: not available.3.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? we have the syringes with the same lot#, but without visible defect.If you would like to have them, our address is: laboratory, sample procurement, (b)(6).4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.The defective syringes were discovered before blood collections, so no harm to patients.All syringes with the same lot number were removed from circulation immediately.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr/additional information/correction - stopper defective / damaged additional information: sample received from lot 3282432, updated to section d and device manufacture date: 10/09/2023 updated to section h correction: following submission of initial mdr, the customer information was not correctly reported.Section e updated to reflect correct customer address.Evaluation: three hundred and forty-three were provided to our quality team for investigation.All samples were received in sealed packages with all applicable product information on the top web.Based upon the unclear reported defect in the verbatim, all samples were visually inspected, and leak tested for leakage past stopper with no defects observed.The condition observed is acceptable per product specification.The reported defect was not identified in the samples received.Therefore, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 3282432.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 5ML LS SP125
• 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: 21270021
• Report Number: 1213809-2025-00051
• Device Sequence Number: 3916598
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: (01)30382903096474
• 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): 03/18/2025

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: 309647
• Device Lot Number: 3282432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown