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	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp4377 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc placed (b)(6) 2021, left arm 41cm catheter length, picc flushed and worked fine.Next day it wasn't working so a cxr was performed which showed a kink in the line neat the 5-6cm mark.Rn retracted the picc but when the kink released the tip was in a sub optimal location so they replaced the line.".
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a kink in the catheter was confirmed, but the exact cause could not be determined from the radiographic image was provided for investigation.What was consistent with a picc was observed overlaying the patient¿s arm in the image.The catheter tubing appeared to be doubled over and the section of tubing that appeared to be doubled over was overlying the patient¿s arm.While the evidence observed on the image does not point to a specific root cause, potential contributing factors include insertion technique, securement technique, and patient movement.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.
Event or Problem Description
It was reported "picc placed on (b)(6) 2021, left arm 41cm catheter length, picc flushed and worked fine.Next day it wasn't working so a cxr was performed which showed a kink in the line neat the 5-6cm mark.Rn retracted the picc but when the kink released the tip was in a sub optimal location so they replaced the line.".

• 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
• MDR Report Key: 12246226
• Report Number: 3006260740-2021-02990
• Device Sequence Number: 4486203
• Product Code: LJS
• UDI-Device Identifier: 00801741154898
• UDI-Public: (01)00801741154898
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1294108D3
• Device Lot Number: REFP4377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other