MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Luer-Lok; Syringe

Catalog Number	309680
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that multiple product quality concerns that have been identified with bd sterile syringes from several lots.Verbatim: complaint via email.Email attached.I am writing to report multiple product quality concerns that have been identified with bd sterile syringes from several lots currently in our inventory.These issues have been observed across multiple syringes and lot numbers, raising concerns regarding product quality and manufacturing consistency.The defects identified include: extra measurement markings printed on syringe barrels black specks present on syringe barrels unidentifiable debris observed within syringe barrels missing graduation markings on the barrel the affected products and lot numbers are as follows: 50 ml sterile syringes lot 6138808: two syringes identified with defects lot 6098162: two syringes identified with defects lot 6098177: two syringes identified with defects lot 6131767: 26 defective syringes identified 5 ml sterile syringe lot 6114407: one syringe identified with missing graduation markings on the side of the barrel these defects were identified during routine inspection.Due to concerns regarding product quality and the potential impact on accurate medication preparation and administration, the affected syringes were immediately removed from use and were not utilized for patient care.The syringes have been retained and are available for return to bd to support your investigation.We would appreciate your assessment of these findings and any guidance regarding product return procedures, replacement product, and investigation activities.Please advise on the next steps for submitting the affected samples, photographs, or any additional information needed to support your review.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

• 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 ; +1(847)393-5694
• MDR Report Key: 50899380
• Report Number: 9610847-2026-00444
• Device Sequence Number: 16130314
• Product Code: FMF
• UDI-Device Identifier: 00382903096800
• UDI-Public: (01)00382903096800
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 309680
• Device Lot Number: Unknown
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown