MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLINE CENTRAL VENOUS CATHETER. 6F TRIPLE-LUMEN POLYURETHANE CATHETER; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	0730615
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2016
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 leak in the catheter was confirmed and the cause appears to be use related.One 6 fr t/l powerline catheter was returned for investigation.The catheter reveals evidence of use.The extension legs exhibited multiple compressions from the clamps.The printing on the molded trifurcation was partially worn.The 0-3 cm depth marks were worn from the tubing.Residue was adhered to the external surface of the catheter between the trifurcation and the cuff.The triple lumen (t/l) tubing extended 21.3cm from the distal end of the cuff.The catheter was in place between (b)(6) 2016.A functional test of the powerline catheter revealed a leak in the non-power injectable lumen with the gray luer adaptor.The leak was located 3.5mm proximal to the cuff.No other leaks were identified in the returned catheter.The leak site was microscopically examined, which revealed a v-shaped hole that pointed toward the proximal end of the catheter from the external surface of the tubing.The edges along the hole were sharp, which is consistent with damage associated with a sharp instrument, such as a needle.The product ifu cautions, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged, atraumatic clamps or forceps.¿ the cutdown technique in the ifu includes the following statement, ¿close the skin at the venipuncture site as necessary, taking care not to damage the catheter.¿ it cannot be verified if the catheter was inadvertently damaged during placement or during use.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rezk0439 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a powerline was inserted on (b)(6) 2016 but a hole was noticed at a follow-up.The radiology department was informed and the line was removed on (b)(6) 2016.The leak was identified a couple of centimeters above the cuff in the subcutaneous tunnel.There was no reported patient injury.

• Brand Name: POWERLINE CENTRAL VENOUS CATHETER. 6F TRIPLE-LUMEN POLYURETHANE CATHETER
• 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: 5855216
• Report Number: 3006260740-2016-00401
• Device Sequence Number: 13612024
• Product Code: LJS
• UDI-Device Identifier: 00801741036637
• UDI-Public: (01)00801741036637(17)200828(10)REZK0439
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2016

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: 08/28/2020
• Device Catalogue Number: 0730615
• Device Lot Number: REZK0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1