MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; 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	07/05/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported, patient presented to ed.Unable to administer antibiotics at home.Attempted to flush line, upon review found 3 kinks in line.Line removed and new line placed.Original line placed on (b)(6) 2024.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 a kinked catheter is confirmed and was determined to be use related.One d/l powerpicc solo was returned for evaluation.An initial visual observation revealed use residues throughout the returned catheter.Circumferentially aligned kinks were observed just distal of the 6 cm depth marker, between the 7 cm and 8 cm depth markers, between the 14 cm and 15 cm depth markers, between the 19 cm and 20 cm depth markers and at the 23 cm depth marker for a total of five observable kinks along the catheter.Kinking of the catheter may occur along the catheter from placement techniques, patient anatomy, securement techniques, or other unknown clinical factors.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, patient presented to ed.Unable to administer antibiotics at home.Attempted to flush line, upon review found 3 kinks in line.Line removed and new line placed.Original line placed on (b)(6) 2024.No other information was provided.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: 19924601
• Report Number: 3006260740-2024-04271
• Device Sequence Number: 8375025
• Product Code: LJS
• UDI-Device Identifier: 00801741155000
• UDI-Public: (01)00801741155000(11)240108(17)250228(10)REHY0852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: S1294108D3
• Device Lot Number: REHY0852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: Other
• Patient Sex: Unknown