MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3274118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recr2469 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the facility had a bard 4f power picc placed (b)(6) 2018 and removed due to leaking on (b)(6) 2018.On (b)(6) 2018- additional information from tm stated the picc was replaced as it was leaking from a "very small" hole near the bifurcation.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 a leak in the catheter was confirmed, but the exact mechanism of damage was unknown.One 4 fr d/l powerpicc sv was returned for investigation.The catheter exhibited evidence of use.The d/l tubing extended to the 40cm depth mark.Areas of discoloration were observed on the molded bifurcation.What was consistent with tape residue was observed on the d/l tubing between the bifurcation and the 4cm depth mark.The tubing was discolored between the 4 and 5 cm depth marks.A functional test revealed a leak between the bifurcation and the 0 mark when the power injectable lumen was infused with water.A longitudinal split that was between 0.5 and 1.0 mm in length was observed in the power injectable lumen.The adjoining surfaces of the split tubing were granular.The wall thickness of the catheter was within specification.Due to the condition of the returned sample, it appeared that the catheter was damaged during use.The observed damage can occur from over-pressurization.Over-pressurization can occur through the use of syringes smaller than 10ml or due to excessive force applied during infusion procedures; however, the exact cause of the split in the catheter was undetermined.A lot history review (lhr) of recr2469 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the facility had a 4 fr power picc placed (b)(6) 2018 and removed due to leaking on (b)(6) 20/18.8/23/2018- additional information from tm stated the picc was replaced as it was leaking from a "very small" hole near the bifurcation.

• Brand Name: POWERPICC SV CATHETER 4F BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• 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: 7847940
• Report Number: 3006260740-2018-02351
• Device Sequence Number: 13770996
• Product Code: LJS
• UDI-Device Identifier: 00801741027840
• UDI-Public: (01)00801741027840
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 3274118
• Device Catalogue Number: 3274118
• Device Lot Number: RECR2469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1