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

Catalog Number	S02320-75
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/25/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The complaint of a bent needle was confirmed, and the cause was determined to be use-related.The product returned for evaluation was one 20 ga x 0.75 in.Miniloc infusion set.The returned product sample was evaluated, and the needle was observed to be bent at the proximal end of the needle shaft.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access.The needle tip was barbed suggesting contact between the needle and port base.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that the tip of the huber needle found crooked.Patient experienced pain and bleeding during insertion of the chemoport needle.Patient reported pain when using the alternative miniloc with injection y-site during chemoport needle insertion.No other information was provided.11/07/2025: the returned device exhibited a bent needle.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23638071
• Report Number: 3006260740-2025-08966
• Device Sequence Number: 15813506
• Product Code: FPA
• UDI-Device Identifier: 00801741048968
• UDI-Public: (01)00801741048968(11)241223(17)270531(10)ASJSFC138
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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 Catalogue Number: S02320-75
• Device Lot Number: ASJSFC138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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