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

Catalog Number	309632
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
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#: 309632, batch#: 4066411.It was reported that the bd luer-lok was mixed product / lots.The following information was provided by the initial reporter: rcc received a complaint via email.During routine use of sp.0171 (i.E., mtn 5250_8) stock, unidentified vendor material (5ml syringe, 21g x 1.5" tw) was found with manufacturer part number: 309633, lot: 4011811 in mtn 5250_8 inventory supply.Investigation on 25nov2024 discovered 298 individual syringe units collected and subsequently quarantined from the accepted lot.However, the original shipment was found in accordance with certificate and specification requirements.Furthermore, 510 units were inspected and found acceptable at time of receipt and the material was not identified at the time of material inspection to determine the true source of 309633.Additional info: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse events or serious injury to report at this time.2.Please reconfirm total number of occurrences.Units found in inventory: (b)(4) individually wrapped syringe, ref: 309633, lot: 4011811.3.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? this is the material that was not ordered but found within inventory of material that was ordered with ref: 309632 4.Given material number#: 309633 is not matching the lot#: 4066411.So please confirm the material number and lot number.Further, confirmation of material received but not ordered, ref: 309633, lot: 4011811.The lot is incorrect as lot: 4066411 corresponds to ref: 309632, the material that was originally ordered and within sofie material acceptance records.Additional info: a total of (5) samples of ref: 309633, lot: 4011811 was sent out yesterday, monday december 16th with the shipping label provided.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.
Event or Problem Description
No additional information received.

• 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: 21060532
• Report Number: 1213809-2024-01017
• Device Sequence Number: 8153189
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320(11)240306(17)290228(10)4066411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 309632
• Device Lot Number: 4066411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown