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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	09/07/2025
Type of Reportable Event	Serious Injury
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported i de-accessed the patient's mediport and the huber needle jabbed me in the finger as i was placing the needle into a sharps box.I had retracted the needle into the safety as i pulled it out and it made a click feeling as if it locked into place.I was surprised when i suddenly felt a needle stick.I looked at the huber and the needle was sticking out about 1/3 of a cm.From the shield.I pulled back and the needle clicked back into the safety shield but when i gently bumped the head of the needle, the sharp point popped back out again part way.Clearly the needle was not locking into the safety shield.Testing was negative for hiv, hep c and hep b.No prophylaxis required.
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 faulty safety mechanism was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 20g x 1.0in.Powerloc infusion set.A gross visual inspection of the returned unit found that the device was returned with the safety mechanism engaged over the needle tip.Microscopic inspection of the device did not identify any damage to the safety mechanism or any other remarkable features.The device was functionally tested by pushing the safety mechanism up and down to see if it could be disengaged with force.The safety mechanism was unable to be disengaged.The safety mechanism was mechanically disengaged, and then re-advanced over the needle to observe for any failure.The safety mechanism advanced and engaged over the needle without issue.The safety mechanism was pushed up and down, again, to see if it could be disengaged with force.The safety mechanism was unable to be disengaged.Based on the available evidence, the customer's reported defect could not be confirmed.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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23767839
• Report Number: 3006260740-2025-09483
• Device Sequence Number: 9656910
• Product Code: FPA
• UDI-Device Identifier: 00801741047923
• UDI-Public: (01)00801741047923(11)240516(17)270731(10)ASJNFC207
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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): 02/10/2026

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 Model Number: N/A
• Device Catalogue Number: 0672010
• Device Lot Number: ASJNFC207
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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