MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that the 018 guidewire's soft tip was too soft, got bent & curved easily when advancing through subclavian vein to brachiocephalic vein.Scrub nurse opened new a powerpicc set and flush all tools with heparinizedsaline.After introducer needle was inserted, scrub nurse helped ir in advancing guidewire into vein.Half way of advancing guidewire through subclavian vein to brachiocephalic vein the soft tip is bent and stuck by coiling inpatient's vein, after a few attempts of trying to advance further the guidewire by flushing with sterile normal saline, ir still experienced difficulty to continue advancing the guidewire to brachiocephalic vein.Ir pulled the 018 stainless steel guidewire out from patient's vein and instructed staff nurse to open a new 018guidewire of competitor's brand to continue with powerpicc insertion procedure.No serious injury to patient.No other information was provided.
Additional Manufacturer Narrative
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 bent guidewire was confirmed but the cause is unknown.A single photograph of the distal end of the implicated guidewire was returned for evaluation.The flexible distal tip of the guidewire contained a curved shape memory; there appeared to be three bends in this location.There were no distinguishing features in the returned photograph which could aid in identification of a specific root cause.It was reported that this occurred while advancing the wire through the subclavian vein and into brachiocephalic vein.Possible contributing factors could include insertion technique or a tortuous insertion path.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that the 018 guidewire's soft tip was too soft, got bent & curved easily when advancing through subclavian vein to brachiocephalic vein.Scrub nurse opened new a powerpicc set and flush all tools with heparinizedsaline.After introducer needle was inserted, scrub nurse helped ir in advancing guidewire into vein.Half way of advancing guidewire through subclavian vein to brachiocephalic vein the soft tip is bent and stuck by coiling inpatient's vein, after a few attempts of trying to advance further the guidewire by flushing with sterile normal saline, ir still experienced difficulty to continue advancing the guidewire to brachiocephalic vein.Ir pulled the 018 stainless steel guidewire out from patient's vein and instructed staff nurse to open a new 018guidewire of competitor's brand to continue with powerpicc insertion procedure.No serious injury to patient.No other information was provided.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19235132
• Report Number: 3006260740-2024-02049
• Device Sequence Number: 7952650
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Model Number: N/A
• Device Catalogue Number: 3275135
• Device Lot Number: REGW0824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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