MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. LUER-LOK; SYRINGE

Catalog Number	305617
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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
It was reported that bd syringe 20ml ll tip conv pak leaked it was reported by customer that batching syringes leaking drug at the plunger area of the syringe.Rcc received a complaint via email.Member: xxxxxxxx vendor: becton dickinson (bd) canada product: syringe, iv, sterile, 20 ml, luer lock, pharmacy bulk tray province: xxxxxxxx lot number: 5195506 expiry: 2030-04 -30 additional lot number: 5129980 problem description: bd 20 ml syringe luer-lok.Bulk sterile convenience pak (10 syringes).Batching syringes leaking drug at the plunger area of the syringeadditional information: can you please provide an exact date of event in format dd-mmm-yyyy? - 12-01-2026 & 14-01-2026.What was the impact to the patient? - to my knowledge issue was found prior to reaching patient what was the medication/fluid in use at the time of the event? - cefazolin 2g 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?.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 3 photo and 5 physical samples submitted for evaluation.The reported issue of leakage past stopper was not confirmed upon inspection of the samples.Analysis of the sample showed that no defect or imperfections were observed to the syringe barrel or syringe rubber stopper.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Please refer to ifu for proper handling and storage recommendations.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: LUER-LOK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24222453
• Report Number: 9610847-2026-00039
• Device Sequence Number: 8392224
• Product Code: FMF
• UDI-Device Identifier: 00382903056170
• UDI-Public: (01)00382903056170(17)300430(10)5129980
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 305617
• Device Lot Number: 5129980
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown