MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM GUIDEWIR; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds1319 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was leaking blood and it needed to be replaced.It was state the user was questioning the valve.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of blood leaking from the valve was confirmed, but the exact cause could not be determined.One 5fr dual-lumen (d/l) powerpicc solo ft was returned for investigation.The catheter was received in two segments.The d/l tubing had been cut at the 8 cm depth mark.The catheter exhibited evidence of use.Non-vad injection caps were attached to each solo connector.A white colored residue was observed on the external surface of each solo connector at the distal end of the injection caps.The printing on the molded bifurcation was partially worn.A functional test revealed fluid leaking from the red solo valve.A microscopic examination of the solo valve revealed residue in the valve.After removing the residue in the valve, the valve remained gaped open and fluid leaked through the valve.The residue did not match any portion of the powerpicc device.After reattaching the injection caps, fluid would not leak from the solo valve.It is possible that the residue was a factor in the reported event and the gaping valve.Due to the condition of the returned sample, it is possible that the valve was damaged during use; however, the exact cause could not be determined.A lot history review (lhr) of reds1319 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was leaking blood and it needed to be replaced.It was state the user was questioning the valve.

• Brand Name: POWERPICC SOLO FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM GUIDEWIR
• 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: 9587924
• Report Number: 3006260740-2020-00072
• Device Sequence Number: 19751435
• Product Code: LJS
• UDI-Device Identifier: 00801741028151
• UDI-Public: (01)00801741028151
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 3295355F
• Device Lot Number: REDS1319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1