MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leak is confirmed and appears to be related to the use of the device.One 5 fr tl powerpicc catheter was returned for investigation.Evidence of use was present within the tubing and extension legs.A securacath label was attached to the purple tubing.A longitudinal split was present in the catheter approximately 3 cm from the proximal end.Tactile evaluation did not reveal any apparent tensile weakness.The sample was flushed with water from the distal end and a complete occlusion was not present.Microscopic observation revealed a longitudinal indentation on the opposite location of the split.The split surface appeared to be smooth; however, the split edges appeared to have slightly jagged steps.The presence of the catheter indentation and split suggest the catheter experienced a pinching compression which was likely caused by the securement method of the device.A lot history review (lhr) of redq3997 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "leaking picc.Hole was seen in line post-removal.It was only in situ for one week and was not used for power injection.A securacath device was used to anchor it in place" additional information received via medwatch 02/19/2020: "leaking picc.Hole was seen in line post-removal.It was only in situ for one week and was not used for power injection.A securecath device was used to anchor it in place".

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• 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: 9732436
• Report Number: 3006260740-2020-00574
• Device Sequence Number: 2401711
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020
• Report Date (Section F): 01/28/2020

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: REDQ3997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56
• Patient Weight: 64
• Date Report Sent to FDA: 01/28/2020