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

Model Number	N/A
Medical Device Problem Codes	Restricted Flow rate (1248); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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
Port needle not reaching its maximum 5mls/second at 300psi.The centargo bayer injector keeps pressuring out and not holding 5mls.No patient harm.These port needles were being tested prior to use on pt.
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 difficulty flushing the infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ powerloc max safety infusion set with y-site.The sample appeared free of obvious use residues.The proximal clamp was engaged on the extension tubing.Following release of the clamp, the tubing remained compressed where the clamp had been applied.Microscopic inspection of the sample confirmed compression of the extension tubing where the clamp was engaged.The sides of the tubing were firmly pressed together, and attempts to separate them were unsuccessful.An attempt to infuse water through proximal luer revealed the proximal extension tubing to be fully occluded.The occlusion was isolated to the kinked region of the tubing.Compression of the extension tubing caused the observed occlusion.That compression occurred where the clamp was engaged on the tubing, suggesting that prolonged engagement of the clamp may have contributed, however, it could not be determined if an additional environmental factor(s) contributed to the tubing shape memory.

• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22359931
• Report Number: 3006260740-2025-04399
• Device Sequence Number: 8705715
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/20/2025

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: 0132075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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