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

Catalog Number	8672034
Medical Device Problem Codes	Restricted Flow rate (1248); Fluid/Blood Leak (1250)
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 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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that bard port needle 20g with y site not reaching 5mls/second at 300psi.Upon testing the bayer centargo injector couldn't reach the advertised 5mls/sec and kept pressuring out.No further information 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 complaint of a reduced flowrate was confirmed and the cause was supplier related.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, leaking was observed at the needle housing.The leaking water emanated from an adhesive application site and the needle exit site.Flushing the sample further revealed that the infusion set was partially occluded, apparently by blood products.Microscopic inspection of the sample confirmed leakage at the needle housing and the presence of blood residue within the fluid path.The partial occlusion appeared to be caused by coagulated blood products within the fluid path.The lack of a complete seal likely allowed blood products to enter the fluid path.The observed leakage was also caused by a lack of complete seal between the extension tubing and needle shaft.It appeared that poor seal was caused by incomplete adhesive coverage/deposition during device assembly.The device is a supplied component and the supplier has been notified of this event.

• 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 84116
• Manufacturer Contact: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22373232
• Report Number: 3006260740-2025-04437
• Device Sequence Number: 12750850
• Product Code: FPA
• UDI-Device Identifier: 00801741048425
• UDI-Public: (01)00801741048425
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060812
• 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): 08/21/2025

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: 8672034
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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