MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C; 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 is pending evaluation.Results are expected soon.A lot history review (lhr) of reds3424 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was leaking in the catheter extension.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 inconclusive due to the state of the returned sample.One photograph of a 5 fr single lumen powerpicc was returned for evaluation.An initial visual observation of the photograph showed a stiffening stylet and t-lock were inserted in the catheter, and the stylet appears to have been pulled out of the t-lock slightly.The red warning hang tag was present on the stylet, and no damage or obvious evidence of use was observed on the catheter in the returned photograph.While it was not possible to confirm the alleged leak or identify the root cause(s) of the reported event from the returned photograph, possible causes of a leak include sharp instrument damage, over-pressurization, and excessive tensile (pulling) force.A lot history review (lhr) of reds3424 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was leaking in the catheter extension.No other information was provided.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C
• 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: 10146094
• Report Number: 3006260740-2020-02079
• Device Sequence Number: 2924435
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• 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): 06/22/2020

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 Model Number: N/A
• Device Catalogue Number: 3175118
• Device Lot Number: REDS3424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1