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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, fluid (fluorouracil) leakage in the area of the connection valves used, spinning spiro, check valve (=k zero adapter) in connection with the elastomeric pump.This has at least the following negative effects: unclear amount of actually infused cytostatic drugs.Skin irritation due to leaking cytostatic drugs.Stressful situation for the patient (psychological component).Endangering third parties through the uncontrolled release of cytostatic drugs.Port needle has been removed.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.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 leaking infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a powerloc max stylet safety infusion set.The portion of the device visible in the photograph included the needle housing and a portion of extension tubing.The device was being used to access an indwelling port and a clear dressing was fixed over the needle housing.Opaque material was visible beneath the dressing.The material under the dressing suggested that leakage likely occurred; however, it could not be determined if the leakage was from the needle housing, tubing or backflow from the insertion site.Neither the precise nature of the leak, nor the root cause could be determined from examination of the provided photograph.
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.

• Brand Name: POWERLOC MAX
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21626644
• Report Number: 3006260740-2025-01552
• Device Sequence Number: 6791451
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435(11)230107(17)251016(10)ASGXFC055
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153440
• 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): 05/16/2025

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 Expiration Date: 10/16/2025
• Device Model Number: N/A
• Device Catalogue Number: 0141975
• Device Lot Number: ASGXFC055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/17/2025; 05/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/09/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• 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