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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer we recently had a patient that had a miniloc malfunction.The safety failed to engage.Per the nurse the lock would click shut and then reopen.This happened 3 times.No patient harm, injury or negative outcome occurred as a result of this event.This report addresses all 3 occurrences.
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 failed safety mechanisms is inconclusive because the third alleged device was not returned for evaluation.Two 20 ga x 0.75 in.Miniloc infusion sets were returned for evaluation.An initial visual observation of the returned infusion sets revealed sample 1 to be returned opened with safety mechanism engaged.Little use residues were observed throughout sample 1.Sample 2 was observed to be returned in its unopened packaging.Nothing remarkable was observed along sample 2.A functional test of attempting to forcibly retract the safety mechanism from the needle tip along sample 1 revealed the safety mechanism remained activated over the needle tip.The safety mechanism of sample 2 was activated along the needle tip.A functional test of attempting to forcibly retract the safety mechanism from the needle tip along sample 2 revealed the safety mechanism remained activated over the needle tip.Because the third alleged infusion set was not returned for evaluation, the complaint of a failed safety mechanism is inconclusive at this time.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 UT 84116
• Manufacturer Contact: carey carter ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21458763
• Report Number: 3006260740-2025-00960
• Device Sequence Number: 7986440
• Product Code: FPA
• UDI-Device Identifier: 00801741048029
• UDI-Public: (01)00801741048029(11)240706(17)261211(10)ASHZFC067
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 0682010
• Device Lot Number: ASHZFC067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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