MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO HF 3CG TPS 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000410

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact cause remains unknown.One radiographic image of a patient was provided for evaluation.The image appears to show the right torso and right arm region.A catheter appears to be present in the right arm and appears to loop on itself creating a kinked region.Based on the image provided, possible contributing factors include manipulation of the catheter during use and securement method.Since the catheter appeared to be kinked, the complaint is confirmed but the exact cause of the kink remains unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "occurred 12/7, out 3 cm on insertion, patient pulled it out further and it kinked.Placed on 11/17 ref ck000410a, this is a 5 french triple lumen powerpicc solo provena picc.".

• Brand Name: POWERPICC SOLO HF 3CG TPS 5F TL
• Type of Device: 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11379778
• MDR Text Key: 234953561
• Report Number: 3006260740-2021-00486
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741096297
• UDI-Public: (01)00801741096297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2021

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
• Device Operator: Health Professional
• Device Model Number: CK000410
• Device Catalogue Number: CK000410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other