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

Catalog Number	S4153108BDP
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that while attempting to advance guidewire, resistance was met.Guidewire withdrawn and repositioning of needle via ultrasound attempted multiple times with unsuccessful wire advancement.Then wire could not be removed from patient arm, even after removal of needle.Guidewire appeared to have folded over itself and created a ¿knot¿.No impact to patient, guidewire successfully removed.No other information provided, at this time.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.
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 knot in the guidewire was confirmed and was determined to be use related.The product returned for evaluation was a nitinol guidewire.Use residue was observed on the guidewire.The coiled section of the guidewire was observed to be slightly deformed and a knot was observed at the distal end.Microscopic inspection of the knot revealed a significant amount of use residue.A misaligned coil was observed near the knot.The weld tip was observed to be present and intact.Repetitive advancing and withdrawing the guidewire during attempted use 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It was reported by customer that while attempting to advance guidewire, resistance was met.Guidewire withdrawn and repositioning of needle via ultrasound attempted multiple times with unsuccessful wire advancement.Then wire could not be removed from patient arm, even after removal of needle.Guidewire appeared to have folded over itself and created a ¿knot¿.No impact to patient, guidewire successfully removed.No other information provided, at this time.

• Brand Name: 3FR SL 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20272691
• Report Number: 3006260740-2024-05370
• Device Sequence Number: 3393969
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003(11)240729(17)250731(10)REJS3712
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 11/15/2024

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: 07/31/2025
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REJS3712
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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: Other
• Patient Sex: Unknown