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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.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 that "trouble-free dialysis catheter insert.After hemodiafiltration, recurrent alarm due to repeated (bubbles clearly visible) air in the aspirating (red) leg.Catheter was changed and then tested with air.A blister formed at the base of the red catheter leg to the white connecting part.Possible consequences: potential air embolism possible".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the extension leg is confirmed but the exact cause is unknown.One 20 cm powertrialysis dialysis catheter was returned for investigation.The sample was returned in open packaging indicating pn: 5608200 and ln: redr0446.Yellow discoloration was visible on the trifurcation hub.Blood residue was present within the extension tubing.One video sample of a trialysis catheter submerged in water was also provided for investigation.The condition of the sample in the video appears to correspond to the returned physical sample.The three luer hubs were flushed with water using a 12 ml syringe.Water was observed to leak in the extension leg with the red luer hub.Microscopic observation revealed a circumferential split.The split edges appeared to be rough and uneven.Based on the characteristics of the split, possible contributing factors include sharp instrument damage or damage during manipulation of the extension leg.The exact factors and conditions of use that contributed to the reported event are unknown; therefore, the complaint is confirmed, cause unknown.A lot history review (lhr) of redr0446 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "trouble-free dialysis catheter insert.After hemodiafiltration, recurrent alarm due to repeated (bubbles clearly visible) air in the aspirating (red) leg.Catheter was changed and then tested with air.A blister formed at the base of the red catheter leg to the white connecting part.Possible consequences: potential air embolism possible.".

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC KIT (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: 9624853
• Report Number: 3006260740-2020-00278
• Device Sequence Number: 2922666
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 5608200
• Device Lot Number: REDR0446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1