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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer ¿at approximately 12:10 i removed a patient's port needle access from their chest and place the locked, presumed retracted needle on the bedside table.Patient was discharged and i returned to clean up her chair.Upon discarding port needle my right thumb was punctured by the needle.Upon further inspection it appears that the safety failed on the device.In the fully locked position the needle was partially exposed on the plate.Clinic was notified and labs were added on to patient's previously drawn blood from earlier in the day.".
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 manufacturer has received the sample and it 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 difficulty advancing the safety mechanism was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 20g powerloc max infusion set.The investigation findings were consistent with misplaced or excess manufacturing adhesive, which bound the safety mechanism to the needle.The following observations were made during the sample evaluation: the safety mechanism was not engaged over the needle tip and was returned positioned at the needle base/ microscopic examination under uv light assistance revealed a white/clear adhesive-like substance at the interface of the needle shaft and safety mechanism.That material fluoresced under ultraviolet light, which was consistent with the adhesive used to assemble the infusion set.From this, it appeared that adhesive was deposited on the needle shaft during device manufacture.The device is a supplied component and the supplier was notified of the event.

• Brand Name: POWERLOC MAX, ALLPOINTS DRESSING KIT
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21752936
• Report Number: 3006260740-2025-01939
• Device Sequence Number: 10161690
• Product Code: PTI
• UDI-Device Identifier: 00801741215209
• UDI-Public: (01)00801741215209
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• 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): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: AN142075B
• Device Lot Number: REJV1625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: Required Intervention
• Patient Sex: Unknown