MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER PROVENA 5F TL 3CG; 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	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter kink is confirmed but the exact cause remains unknown.One x-ray image sample of a powerpicc catheter was provided for evaluation.The catheter appears to be inserted within the patient¿s arm.The molded wing hub is partially visible.The catheter extending from the hub appears to twist with itself creating a kinked region.The catheter appears to be bunched together forming an ¿n¿ shape creating two kinked regions.Based on the information provided, possible contributing factors include placement location, securement method, and patient anatomy.Since a kink appears to be visible in the x-ray image provided, the complaint is confirmed but the exact cause remains unknown at this time.A lot history review (lhr) of refn0795 showed one other similar product complaint(s) from this lot number.The complaints for this lot number refn0795 have been reported from the same facility.
Event or Problem Description
It was reported that the picc kinked.The picc was placed in the left arm.It was stated that the patient had a larger arm.Add info rcvd 05/24/2021: was there patient harm reported?: no.

• Brand Name: POWERPICC SOLO CATHETER PROVENA 5F TL 3CG
• 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: 11980050
• Report Number: 3006260740-2021-02289
• Device Sequence Number: 1085788
• Product Code: LJS
• UDI-Device Identifier: 00801741163296
• UDI-Public: (01)00801741163296
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: CK000869
• Device Lot Number: REFN0795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/10/2021
• 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
• Patient Weight: 272