MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL BAR; 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)
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 reds2355 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that powerpicc was found leaking.No other information was provided.
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 leak is confirmed and was determined to be use related.One 4 fr single lumen powerpicc was returned for evaluation.An initial visual observation showed use residue on the returned sample.A small split was observed in the extension leg of the catheter, about 8 mm proximal to the molded joint.A microscopic observation revealed the edges of the split were well-defined and mostly straight, and striations were observed on the fracture surfaces, which were found to be flat and reflective, which is characteristic of damage caused by contact with a sharp-edged instrument such as a scalpel.The product ifu states: ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smoothened atraumatic clamps or forceps.¿ a lot history review (lhr) of reds2355 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that powerpicc was found leaking.No other information was provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL BAR
• 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: 9354482
• Report Number: 3006260740-2019-03633
• Device Sequence Number: 2708758
• Product Code: LJS
• UDI-Device Identifier: 00801741035555
• UDI-Public: (01)00801741035555
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: 9174108D
• Device Lot Number: REDS2355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1