MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC; MIDLINE CATHETER

Catalog Number	0632234
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that while using the miniloc safety infusion set, specifically with the blue plastic end part that screws onto the clave, they noticed when they were running a saline infusion that there was a leak where the infusion set connects with the clave.After trying several claves with different lot numbers, the problem persisted.A new infusion set from the same lot was used and the problem continued.Then they used a clave from one of the lots they had tried but changed to an infusion set from a different lot and that finally fixed the issue.It was reported this occurred with two devices.This report addresses both devices.No further information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of leaking infusion sets is inconclusive.Five sealed 22 ga x 0.75 in.Miniloc infusion sets were returned for evaluation.The returned sealed lot samples were evaluated and no obvious damage was observed.A functional test of flushing and pressurizing the samples with water using a 12 ml syringe was performed.No leaks were observed from any of the samples.A microscopic observation revealed no evidence of breach or split on the connections between the tubing and the luer adaptors.The complaint of a leak was inconclusive because the implicated samples were not returned to bd for evaluation.The event detail and provided information were evaluated.The investigation included a review of historical customer complaints for this batch.Additionally, this information was assessed for the potential of this event to be within scope of an existing capa or scar.Following a review of the entirety of this information, the root cause for this specific event was ultimately inconclusive.In this instance the implicated product samples would be required to confirm the event and assess the potential root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: MINILOC
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24498054
• Report Number: 3006260740-2026-01345
• Device Sequence Number: 10115249
• Product Code: FPA
• UDI-Device Identifier: 00801741047602
• UDI-Public: (01)00801741047602(11)251023(17)280514(10)ASKSFC043
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: Lay User/Patient
• Device Catalogue Number: 0632234
• Device Lot Number: ASKSFC043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown