MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (20CM) (TRIPLE-; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).
Event or Problem Description
It was reported that the catheter came out after being secured by the detachable suture wings.The facility stated that the suture part on the securement device of the catheter has a detachable piece that comes off and the catheter can move through the piece.The suture site attached to the catheter also spins and can lead to catheter dislodgement.They state that it had happened previously.No patient injury reported.
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 that the catheter came out after only being secured by the detachable suture wing could be confirmed due to the condition of the returned sample.One 20cm trialysis catheter was returned for investigation.Residue from use was observed in the extension legs.The rotatable suture wing was in its correct position.The removable suture wing was received separate from the catheter.There was no evidence that sutures had been tied around the suture wing.The product ifu states, ¿when placing the catheter, use the removable suture wing to minimize movement at the exit site.Using your fingers, squeeze the suture wing together so that it splits open and place the wing around the catheter near the venipuncture site.Secure the wing onto the catheter by tying sutures around the wing using the suture grooves.Secure the removable wing in place by suturing through the holes or by using adhesive wound closures.¿ since the suture wing was received separate from the catheter and no evidence of securing the wing to the catheter was observed, the complaint was determined to be use related.Regarding the rotatable suture wing, the product ifu states, ¿the rotatable, pre-attached suture wing is oriented to the skin surface and the catheter is attached using a suture.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).
Event or Problem Description
It was reported that the catheter came out after being secured by the detachable suture wings.The facility stated that the suture part on the securement device of the catheter has a detachable piece that comes off and the catheter can move through the piece.The suture site attached to the catheter also spins and can lead to catheter dislodgement.They state that it had happened previously.No patient injury reported.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (20CM) (TRIPLE-
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7212396
• Report Number: 3006260740-2018-00030
• Device Sequence Number: 11008049
• Product Code: NIE
• UDI-Device Identifier: 00801741041860
• UDI-Public: (01)00801741041860
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018
• Report Date (Section F): 01/03/2018

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: N/A
• Device Catalogue Number: 5603200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR