MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 22G X 0.75CM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Failure to Infuse (2340); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
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 device has not been received by the manufacturer for evaluation.
Event or Problem Description
It was reported when unpacking the implanted port needles, one case had the introducer needle wobbling and not in the slot.The customer replaced the needle with a new one.No other information was provided.
Event or Problem Description
It was reported, when unpacking the implanted port needles, one case could not be primed with fluid.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 complaint of unable to infuse into the infusion set is confirmed and was determined to be use-related.One 22 ga x 0.75 in powerloc infusion set was returned for evaluation.An initial visual observation showed use residues throughout the returned infusion set.A functional test of attempting to infuse water into the powerloc infusion set using a 12 ml syringe revealed the device to be fully occluded.A microscopic observation revealed the distal needle tip to be barbed.A foreign substance was observed at the distal end of the needle shaft appearing to be use residues causing a full occlusion at the distal end of the needle shaft.Observations of the returned powerloc infusion set revealed no potential damage/defect related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75CM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20734027
• Report Number: 3006260740-2024-06542
• Device Sequence Number: 12860880
• Product Code: FPA
• UDI-Device Identifier: 00801741048364
• UDI-Public: (01)00801741048364(11)220622(17)250308(10)ASFWF906
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/13/2025

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: 03/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 8652234
• Device Lot Number: ASFWF906
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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