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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a y-connector is separated from the main body.
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 the event was not provided by the complainant/reporter; the date reflected in this report is the date on which bd became aware of the event.The manufacturer has received the sample and it will be evaluated.A supplemental report will be submitted with evaluation results.
Event or Problem Description
Additional information received on 8/29/2025: the event was discovered when preparing the port needle to insert in the patient.There was no patient harm.
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 damaged infusion set is confirmed; however, the exact cause is unknown.One photograph of a damaged infusion set was returned for evaluation.An initial visual observation of the photograph showed the extension tubing had separated from the y-site.The safety mechanism was not activated and the needle cover was present.No obvious use residue was observed on the sample.No details of the break site could be discerned from the returned sample.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Additional Manufacturer Narrative
H11: the initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

• 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22909437
• Report Number: 3006260740-2025-06315
• Device Sequence Number: 21104527
• Product Code: FPA
• UDI-Device Identifier: 00801741048395
• UDI-Public: (01)00801741048395
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: UNKNOWN
• 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,Followup
• Report Date (Section B): 10/13/2025

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 Model Number: N/A
• Device Catalogue Number: 8671934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/13/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/16/2025
• 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