MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER KIT GUARDIVA, PROBE COVER NEEDLE GUIDE; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1395108D3
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer of a midline kit with a safety needle issue.No other information provided, at this time.
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 is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported this was a triple lumen picc kit.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of safety mechanism detachment was confirmed and the cause appeared to be related to device manufacture.The product returned for evaluation was one 21ga securloc safety introducer needle.Blood residue was visible within the luer adapter.The safety mechanism was received completely detached from the needle shaft.The safety canister appeared intact and contained the spring clip.Microscopic inspection of the safety mechanism components revealed that they appeared well-formed and unremarkable.The safety mechanism was disassembled and reassembled on the needle shaft.A subsequent attempt to activate the safety was successful and unremarkable.The safety mechanism of a non-complainant needle was disassembled and intentionally misassembled.A subsequent attempt to activate the safety mechanism was unsuccessful, as the safety cannister completely detached from the needle shaft.Given that the safety mechanism functioned as intended following proper reassembly on the needle shaft, it is reasonable to conclude that the initial detachment was likely caused by incorrect initial assembly during product manufacture.This conclusion is further supported by duplication of the event by intentionally misassembling a non-complainant safety/needle assembly.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER KIT GUARDIVA, PROBE COVER NEEDLE GUIDE
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21140121
• Report Number: 3006260740-2024-08364
• Device Sequence Number: 7516857
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024(11)240829(17)251231(10)REJU2629
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 04/16/2025

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: 12/31/2025
• Device Catalogue Number: S1395108D3
• Device Lot Number: REJU2629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: Other
• Patient Sex: Unknown