MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebq1104 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was leaking at or near the solo valve and/or the first 1-5 cm of catheter (under the skin).No harm to the patient was observed.Picc was replaced with a new picc.
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; however, the exact cause is unknown.One 4 fr single lumen powerpicc solo was returned for evaluation.An initial visual observation showed use residue throughout the sample and the ink on the extension leg was observed to be faded.The sample was flushed and pressurized with a 12 ml syringe of water and no leaks were observed.However, when the catheter was filled with water and held vertically with the luer hub on top, water was observed to leak from the distal end of the catheter, indicating the solo valve was malfunctioning.A microscopic observation of the solo valve revealed a small, diagonal split on one of the smaller aspiration valves.The luer hub was dissected and the valve was extracted for closer inspection.The edges of the split were observed to be distinct and striations were observed on the fracture surface of the split.The observed features of the split in the valve indicate the valve was damaged by a ground-sharpened instrument.However, it is unknown when or where the valve may have come in contact with a sharp instrument.It is possible the valve was damaged during manufacturing or assembly of the valve or during use.The manufacturing facility was made aware of this event.
Event or Problem Description
It was reported that the picc was leaking at or near the solo valve and/or the first 1-5 cm of catheter (under the skin).No harm to the patient was observed.Picc was replaced with a new picc.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8533346
• Report Number: 3006260740-2019-01098
• Device Sequence Number: 13889371
• Product Code: LJS
• UDI-Device Identifier: 00801741119088
• UDI-Public: (01)00801741119088
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000504A
• Device Lot Number: REBQ1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement 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