MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx0398 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a hole was discovered in the picc in the ct port after the patient had a ct scan.On (b)(6) 2019 - additional information received stated, "a triple lumen picc line was exchanged on this date due to the middle, ct approved port showed a sizable hole in the catheter after a ct injection of contrast.The original picc line was placed on (b)(6) 2019.The patient was not harmed, however, required a new line to be placed.".
Event or Problem Description
It was reported that a hole was discovered in the picc in the ct port after the patient had a ct scan.4/30/2019-additional information received stated, "a triple lumen picc line was exchanged on this date due to the middle, ct approved port showed a sizable hole in the catheter after a ct injection of contrast.The original picc line was placed on (b)(6) 2019.The patient was not harmed, however, required a new line to be placed.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: sample evaluation, patient severity, complaint and lot history, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole in the catheter was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr t/l powerpicc catheter.The sample had previously been trimmed at the 21cm depth marking and usage residue was seen throughout.Gross visual evaluation of the device revealed a permanent kink impression at the 1cm depth marking and a longitudinally-aligned split at the 4cm depth marking.Microscopic examination of the split revealed that it was centered about a permanent kink impression at the same location.Kinking the catheter at that location showed that the split length matched the length of stressed catheter material at the kink site.From the observed damage, it appeared that the catheter had split due to cyclic kinking which had gradually formed a crack at that site.

• Brand Name: POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8600055
• Report Number: 3006260740-2019-01353
• Device Sequence Number: 19406687
• Product Code: LJS
• UDI-Device Identifier: 00801741028205
• UDI-Public: (01)00801741028205
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 3385355Q
• Device Lot Number: RECX0398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1