MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO SP 4F DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of kinked stylets was confirmed; however, the root cause was not identified.The product returned for evaluation was one three 4fr d/l powerpicc provena catheter kits.All three kits were received in their original sealed packages.The packages were unremarkable.The kits were opened and the included guidewires, catheters and inlaid stylets were inspected.The components appeared unremarkable.The lengths of the magnet strings were measured in all three stylet and found to be within manufacturing specifications.Microscopic inspection of the returned guidewires, catheters and stylets was unremarkable.The magnets within all three stylets were counted and found to be within manufacturing specifications.Also received were two photographs which depicted 3cg tls stylets.Both photographs depicted the plastic-coated regions of the wires, including the distal tip epoxy.Usage residues were observed on the stylet wires.Kinks were observed in both stylets approximately midway along the length of the plastic-coated regions.Both stylets appeared to be intact.No deficiencies were discovered during evaluation of the returned lot samples; however, the stylets depicted in the attached photographs both exhibited kinks within the plastic-coated regions.Inspection of the photographs was insufficient to determine a cause for the observed kinking.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include complete removal and re-insertion of the stylet during catheter trimming, insertion of the stylet past the tip of the trimmed catheter, and stylet manipulation prior to or during attempted use.A batch history review (bhr) of regq1413 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "dr.Has identified quality issues with our bard powerpicc provena lines.There is no specific differentiation for what piccs we are seeing the issue with (single vs dual, 3-5fr).Wire pulls out smoothly, but then noted to have be bent to the point of nearly breaking.Risk is of dislodgment in the line/vessel".It was reported this occurred with two devices.This report addresses the first device.

• Brand Name: DOT PROV SOLO SP 4F DL
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16371604
• Report Number: 3006260740-2023-00426
• Device Sequence Number: 6813834
• Product Code: LJS
• UDI-Device Identifier: 00801741134197
• UDI-Public: (01)00801741134197
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1294108PD
• Device Lot Number: REGQ1413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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