MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 3F BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9173118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 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 that the hub of the catheter broke off was inconclusive since the returned catheter was incomplete.One 3fr s/l powerpicc sv was returned for investigation.The luer adaptor was not returned for investigation.The catheter exhibited evidence of use.Dry blood residue was observed within the extension leg and a tacky residue was observed on the external surface of the extension leg and bifurcation.The extension leg extended 3.7cm from the molded wing and the connector was not attached to the extension leg.The cross section at the proximal end of the extension leg was glossy and striated, which indicated that the extension leg had been cut.There was no evidence of a break and since the connector was not returned for investigation, complaint was inconclusive.The catheter tubing extended 8.1cm from the distal end of the molded wing and an 8.8cm contiguous segment of tubing was received separate from the main body of the catheter.All ends of the returned catheter segments exhibited evidence of being cut with a sharp instrument.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 by the facility that the hub on the catheter broke off at home, clamped the line and patient was immediately taken to the emergency department where the line was removed and a new line placed.No harm to the patient.

• Brand Name: POWERPICC SV CATHETER 3F BASIC TRAY WITH MICROINTRODUCER (SINGLE-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: 7234987
• Report Number: 3006260740-2018-00093
• Device Sequence Number: 140091
• Product Code: LJS
• UDI-Device Identifier: 00801741028571
• UDI-Public: (01)00801741028571
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: Lay User/Patient
• Device Model Number: 9173118
• Device Catalogue Number: 9173118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO