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

Catalog Number	0141910
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, paravascular leakage occurs even when correctly positioned, both inside and outside the patient; the needle is extremely difficult to remove.No other 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.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 received 12/29/2025: no patient harm occurred.
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 was unconfirmed as the problem could not be reproduced.Two 19 ga x 1.0 in powerloc max infusion sets were returned for evaluation.An initial visual observation of the returned samples revealed that the samples did not have the safety mechanisms engaged.Clinical use residue was noted on both samples.A microscopic observation revealed the tips of the needles were severely barbed and curled inward.A functional test of flushing and pressurizing the sample was performed.No leaks were observed.Because the alleged leak could not be reproduced during sample evaluation, it is unclear whether the issue originated from unknown clinical conditions or the implicated sample with the issue was not returned.Due to the lack of definitive evidence, this complaint was unconfirmed at this time.No potential damage related to the manufacturing process was noted on the complaint samples.The ifu instructs, "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, the needle and/or port may be damaged at insertion; if too short, the needle may not completely pierce the port septum, and medication may be delivered into surrounding tissue and/or the needle may be blocked." it is unknown if needle selection or needle positioning were contributing factors to the reported issue.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC
• 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: 23958422
• Report Number: 3006260740-2025-10194
• Device Sequence Number: 5610354
• Product Code: FPA
• UDI-Device Identifier: 00801741047411
• UDI-Public: (01)00801741047411(11)250321(17)271205(10)ASJZFC014
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K073050
• 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,Followup,Followup
• Report Date (Section B): 03/04/2026

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: 0141910
• Device Lot Number: ASJZFC014
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 03/04/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/14/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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