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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "transfused a patient's treatment without issue however on disconnecting and flushing the line it blocked.Myself and two other nurses assessed the patient and the needle, ultimately removing it.We tried to flush it when it was out of the patient and it really wouldn't let us, it was totally blocked.We re-accessed the patient with a new needle and flushed the port without issue, providing it was not the port that was a problem." (b)(6) 2025 - during evaluation, a small grey material was found within the tubing of the infusion set.
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 an occluded infusion set is confirmed and was determined to be use related.One 22 g powerloc infusion set was returned for evaluation.An initial visual observation showed use residue on the returned sample.A grey needleless injection cap was returned on the luer hub of the device.An attempt was made to flush the returned sample with a 12 ml syringe of water; however, the returned sample was found to be occluded near the needle housing.A microscopic observation revealed a small, grey material occluding the proximal end of the needle within the tubing of the device.This material was observed to be soft and pliable and was found to be similar in texture and appearance to the material of the valve of the needleless injection cap returned on the luer hub of the device.Additionally, the outer surface of the valve of this needleless injection cap was observed to be damaged, suggesting the valve of the needleless injection cap may have been cored by insertion of a needle which caused the material to become dislodged and ultimately occlude the needle of the infusion set.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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22007053
• Report Number: 3006260740-2025-03045
• Device Sequence Number: 5355900
• Product Code: FPA
• UDI-Device Identifier: 00801741048302
• UDI-Public: (01)00801741048302(11)240704(17)270920(10)ASJQFS007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 05/09/2025

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: 8651934
• Device Lot Number: ASJQFS007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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