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

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 a catheter split is confirmed and appears to be related to the use of the device.One 3 fr powerpicc sv catheter was returned for investigation.The catheter extended up to the 20 cm depth marker.Use residue was observed throughout the sample.The distal end was observed to be occluded.A circumferential split was observed at the proximal end of the catheter extending from the hub.Microscopic observation of the split surface revealed it to be rough and uneven.The section where the catheter was still attached was observed to have material whitening and stretching.The complainant also provided the notes charts which stated the catheter was found to be out 5 cm upon during discovery of the leak.Based on the characteristics of the catheter damage and description of the reported event, the catheter damage was likely caused by material fatigue and excessive tensile forces; therefore, the complaint is confirmed to be related to the use of the device.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that picc was found to be fractured when flushing.No patient harm reported.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXI
• 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: 8724315
• Report Number: 3006260740-2019-01742
• Device Sequence Number: 2221191
• Product Code: LJS
• UDI-Device Identifier: 00801741087103
• UDI-Public: (01)00801741087103
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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
• Report Date (Section B): 06/21/2019

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: 1173108D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1