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

Catalog Number	305617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that one incident leading to patient adverse reaction.In the first incident, a group of syringes broke at the phalange while being stored in a freezer with reconstituted cefepime 2 g in 20 ml sterile water.In the second incident, a syringe tip broke off in an iv infusion line y-site after administration of cefepime 2 g in 20 ml sterile water.Rcc received a complaint via web.Pir attached.There have been two incidents at my institution xxxxxxxxxx) where these 20 ml luer lock syringes broke, with one incident leading to patient adverse reaction.In the first incident, a group of syringes broke at the phalange while being stored in a freezer with reconstituted cefepime 2 g in 20 ml sterile water.In the second incident, a syringe tip broke off in an iv infusion line y-site after administration of cefepime 2 g in 20 ml sterile water.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 24594480
• Report Number: 9610847-2026-00105
• Device Sequence Number: 21451370
• Product Code: FMF
• UDI-Device Identifier: 00382903056170
• UDI-Public: (01)00382903056170
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown