MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR T/L POWERPICC SOLO, 70 CM NITINOL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3396355
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, 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 a crack in the white connector was confirmed, but the exact mechanism could not be determined.One 6fr triple-lumen (t/l) powerpicc solo was returned for investigation.The t/l tubing extended 17.0cm from the distal end of the trifurcation.Residue from use was observed on the trifurcation and extension legs.Cracks were visible in the white connector and a portion of the threaded end of the connector broke away and was not returned for investigation.A non-bas needleless injection cap was returned for investigation.No damage or deformation was observed on the injection cap.A functional test revealed the cracks would gape open when a syringe was attached to the white connector.An attempted to infuse water through the catheter revealed fluid leaking from the cracks in the white connector.A portion of the white connector fractured away during the testing procedure.A microscopic examination of the connector revealed that the fractured surfaces were rough, granular, and jagged.The plane of the fracture passed through a void that was less than 1mm in diameter in the molded white material.No damage was found in the red or gray connectors and the luer taper was found to be within specification.A lot history review (lhr) of rebn0672 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility stated the hub cracked.No patient injury was reported.

• Brand Name: 6 FR T/L POWERPICC SOLO, 70 CM NITINOL
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6446587
• Report Number: 3006260740-2017-00340
• Device Sequence Number: 16285533
• Product Code: LJS
• UDI-Device Identifier: 00801741028502
• UDI-Public: (01)00801741028502(17)171231(10)REBN0672
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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 Expiration Date: 12/31/2017
• Device Catalogue Number: 3396355
• Device Lot Number: REBN0672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1