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
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 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
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of barrel / flange damaged and tip breakage were confirmed upon inspection of the photos.Analysis of the photos showed that in one photo eight syringes can be observed and the syringe barrel flange is damaged and in the other photo a connector with a syringe barrel luer tip.Bd determined that the cause of the failure was the handling and storage of the syringes by the customer as these syringes are not designed to be stored in a freezer.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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: 24597967
• Report Number: 9610847-2026-00104
• Device Sequence Number: 9561492
• 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
• 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: 05/05/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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