MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOLGW; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3194335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that when changing the cap of the picc line with valve, a serological (human fluid) return of blood was noted drop by drop.It was stated the valve inside the picc line did not seem to close.In the icu, the neutral pressure procedure was applied during the irrigation of the picc line, which wants to keep the plunger depressed for a few seconds to return the valve.The administration of the antibiotic therapy was completed.Patient was not injured and picc line removed for another unknown medical reason.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of blood backflow was confirmed; however, the precise root cause was not identfied.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Usage residues were abundant throughout the sample.Microscopic inspection of the valve revealed material caught between the mating surfaces.The valve appeared to be stuck open by that material.The material appeared consistent with the silicone valve material.The sample was charged with water then held vertically with the luer adapter toward the ground.Water was observed leaking from the luer orifice.Following removal of the valve, microscopic inspection revealed a hole at one end of the infusion slit.A split extended into the hole.The hole was larger on the inside surface.The edges of the hole exhibited regular striations.The direction of those striations indicated a curving blade path.The occluding material length and the long axis of the hole were measured using a digital microscope and were found to be similar in dimension.Valve functionality was impeded by the material caught in the valve, which appeared to correspond to the hole in the valve material.It appeared that the valve was damaged, and that material was subsequently deposited between the mating surfaces of the infusion slit during device use.The position and characteristics of that hole indicated that damage was caused by contact with a sharp instrument, and likely occurred before the valve/hub was assembled, possibly during the valve slitting process.Photographs of the sample have been submitted to the manufacturing site for further evaluation.Based on the manufacturing site evaluation, the precise root cause for the valve damage could not be identified.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 when changing the cap of the picc line with valve, a serological (human fluid) return of blood was noted drop by drop.It was stated the valve inside the picc line did not seem to close.In the icu, the neutral pressure procedure was applied during the irrigation of the picc line, which wants to keep the plunger depressed for a few seconds to return the valve.The administration of the antibiotic therapy was completed.Patient was not injured and picc line removed for another unknown medical reason.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOLGW
• 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: 7848032
• Report Number: 3006260740-2018-02355
• Device Sequence Number: 1565529
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2018

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: 3194335
• Device Catalogue Number: 3194335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1