MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/24/2024
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported the 21g access needle safety did not engage properly, the safety was slid down the shaft of the needle and just slid off the tip of the needle and the clinician experienced a needle stick.No consequences for patient.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 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 disassembled.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 disassembling a non-complainant safety/needle assembly.The manufacturing site confirmed that device assembly likely resulted in the observed failure.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Common Device Name: MIDLINE CATHETER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20489257
• Report Number: 3006260740-2024-06037
• Device Sequence Number: 4209004
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164(11)240719(17)250731(10)REJS3844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• 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): 04/07/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REJS3844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 10/19/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: Required Intervention
• Patient Sex: Unknown