MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG); 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	06/07/2024
Type of Reportable Event	Malfunction
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 that have placed a total of 4 mid-thigh catheters with the following reference (b)(4) and lot numbers rejq0717.3 of these lines we have documented kinks that have resulted in line removal and the last line i¿ve had to cathflo about 3 times already since it was placed.All catheters are significantly kinked at 6/7cm mark and 35 cm mark.No issues upon insertion.Verified by x-ray upon placement.All lines placed mid-thigh at bedside.No serious injury, but patients received unnecessary alteplase administration, delay in treatment due to line not working, and one patient required the insertion of a tunneled catheter.This report addresses the first device.
Event or Problem Description
It was reported that have placed a total of 4 mid-thigh catheters with the following reference (b)(4) and lot numbers rejq0717.3 of these lines we have documented kinks that have resulted in line removal and the last line i¿ve had to cathflo about 3 times already since it was placed.All catheters are significantly kinked at 6/7cm mark and 35 cm mark.No issues upon insertion.Verified by x-ray upon placement.All lines placed mid-thigh at bedside.No serious injury, but patients received unnecessary alteplase administration, delay in treatment due to line not working, and one patient required the insertion of a tunneled catheter.This report addresses the first device.
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.
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 catheter kink was confirmed.The product returned for evaluation was three used 5fr dl powerpicc solo catheters.Gross visual and microscopic inspection of units 01 and 03 were unremarkable.Therefore, the investigation will focus on unit 02.Inspection of the catheters found that one of the units (unit 02) had a kink in the tubing at four different locations.One between the 6cm-7cm depth markers, one between the 7cm-8cm depth markers, one between the 30cm-31cm depth markers and one at the 35cm depth marker.Microscopic inspection found that each kink had an elliptical shape and the damage was circumferentially aligned.Additionally, the kinks between the 6-7cm and 7-8cm depth markers had c-shaped impressions (material buckling) and white discoloration of the tubing material at the damage site.This was indicative of material fatigue.However, the other two kinks did not exhibit the same features and no evidence was observed to help identify a root cause for the other two kinks.A wall thickness measurement was taken and the catheter was found to be within specification.Based on the available material for review, it is likely that material fatigue due to physiological, placement, usage, and mechanical factors contributed to some of the observed damage.However, there is insufficient evidence to conclusively determine a root cause.
Event or Problem Description
It was reported that have placed a total of 4 mid-thigh catheters with the following reference s1274108d5 and lot numbers rejq0717.3 of these lines we have documented kinks that have resulted in line removal and the last line i¿ve had to cathflo about 3 times already since it was placed.All catheters are significantly kinked at 6/7cm mark and 35 cm mark.No issues upon insertion.Verified by x-ray upon placement.All lines placed mid-thigh at bedside.No serious injury, but patients received unnecessary alteplase administration, delay in treatment due to line not working, and one patient required the insertion of a tunneled catheter.This report addresses the first device.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG)
• 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: 19651076
• Report Number: 3006260740-2024-03424
• Device Sequence Number: 17796355
• Product Code: LJS
• UDI-Device Identifier: 00801741155154
• UDI-Public: (01)00801741155154(17)250630(10)REJQ0717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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,Followup
• Report Date (Section B): 03/07/2025

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S1274108D5
• Device Lot Number: REJQ0717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• 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: 02/10/2025; 03/06/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 03/06/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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