MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2024
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 evaluate.Results are expected soon.
Event or Problem Description
It was reported via medwatch that access to vein obtained, inserted wire through catheter, pulled catheter out.Advanced wire and patient complained of pain, pulled wire back.Healthcare provider was able to pull wire back a few centimeters, and then it was stuck with resistance felt.Patient required interventional radiology (ir) intervention for removal.Midline was placed in left upper arm.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 difficulty withdrawing the guidewire is confirmed and was determined to be use related.The product returned for evaluation was a nitinol guidewire.The coiled section of the guidewire was observed to be bent in multiple locations and a knot was observed at the distal end.Use residue was observed on the sample.Microscopic inspection of the knot revealed the coiled wire was misaligned in multiple places.The weld tip was observed to be present and intact.Repetitive advancing and withdrawing the guidewire likely caused a knot to form in the guidewire making removal difficult.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported via medwatch that access to vein obtained, inserted wire through catheter, pulled catheter out.Advanced wire and patient complained of pain, pulled wire back.Healthcare provider was able to pull wire back a few centimeters, and then it was stuck with resistance felt.Patient required interventional radiology (ir) intervention for removal.Midline was placed in left upper arm.No other information was provided.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19650977
• Report Number: 3006260740-2024-03422
• Device Sequence Number: 6624982
• Product Code: PND
• UDI-Device Identifier: 00801741154027
• UDI-Public: (01)00801741154027(11)231128(17)250331(10)REHX0528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S4153108DGP
• Device Lot Number: REHX0528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White