MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4fr s/l powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed approximately midway along the extension tube.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.The product ifu states ¿avoid accidental device contact with sharp instruments¿.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of recz3250 showed no other similar product complaint(s) from this lot number.[(b)(4)].
Event or Problem Description
It was reported "single lumen picc with cut to external tubing in clamp area.Pt states home health nurse did weekly dressing change on picc site and immediately after picc flushed the external tubing had a leak.Pt went to ed with complaint of painful blood/fluids leaking from picc line and unable to flush line.Concern about possible fracture of picc line.Patient taken to surgery for replacement of picc line".

• Brand Name: DOT PPICC 4F SL 3CG
• 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: 8659018
• Report Number: 3006260740-2019-01535
• Device Sequence Number: 2274727
• Product Code: LJS
• UDI-Device Identifier: 00801741155741
• UDI-Public: (01)00801741155741
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2019
• Report Date (Section F): 05/10/2019

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 Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000854
• Device Lot Number: RECZ3250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 05/10/2019