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

Model Number	N/A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported upon opening, foreign matter such as cardboard fragments was found.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 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 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 foreign material present packaging is confirmed.One 19ga x 0.75in powerloc infusion set was returned for evaluation.An initial visual observation revealed the infusion set was returned in an open packaging and appeared to be free of use residue.A small brown piece of material was observed between the label and the clear side of the packaging, but no evidence of the brown material was observed within the packaging or in contact with the infusion set.A microscopic observation revealed the material was observed to be fibrous and brown, indicating it was likely a small piece of cardboard.No evidence of compromise or breach of sterile barrier was identified.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 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23469659
• Report Number: 3006260740-2025-08371
• Device Sequence Number: 8727698
• Product Code: FPA
• UDI-Device Identifier: 00801741151453
• UDI-Public: (01)00801741151453(11)250126(17)280324(10)ASJWFC088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 0671934J
• Device Lot Number: ASJWFC088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2025
• 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