MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC; PORT ACCESS NEEDLE

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that tubing connected to the port needle was severed.No further details available or 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.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.
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.
Event or Problem Description
Additional information provided 11/10.Medications infused 10/22-10/25: blinatumomab.
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 a tubing break for an infusion set is confirmed, but the root cause could not be determined.One 20 ga x 1.0 in.Miniloc infusion set was returned for evaluation.An initial visual observation of the returned infusion set showed abundant blood residues inside the tubing of the device.The tubing of the device was broken, and the luer of the infusion set was not returned for evaluation.A tactile evaluation of the tubing of the miniloc infusion set revealed some tensile weakness along the tubing of the device.A microscopic observation of the returned device showed striations along the break site of the infusion set tubing.Clear residues were observed around the break site and along the fracture surface.The root cause of this failure could not be determined; however, possible causes of failure include excessive pulling forces on the extension tubing, insufficient adhesive application of adhesive between the extension tubing and luer, or other unknown causes.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: MINILOC
• Common Device Name: PORT ACCESS NEEDLE
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23527032
• Report Number: 3006260740-2025-08560
• Device Sequence Number: 9141361
• Product Code: FPA
• UDI-Device Identifier: 00801741047541
• UDI-Public: (01)00801741047541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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 Model Number: N/A
• Device Catalogue Number: 0632010
• Device Lot Number: UNKNOWN
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 01/13/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/25/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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