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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.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 at the start of the rn's shift, it was noted the patient's trialysis line was sutured but that the hub wasn¿t sutured and so they attempted to secure it better with stereo strips.It was stated around 0200, the rns were reintubating and positioning the patient and his line became dislodged.The rn went to prepare to push drugs and noticed it was out about an inch and a half from previous location.After removing, rns noted that the suturing adaptor had moved from it¿s original location (picture 1), to further down the line (picture 2).Rn states she doesn't know if it was intentionally sutures that way before but that it created an unsafe situation as the line moved position while cvvhd was running.A new catheter was placed.
Additional Manufacturer Narrative
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 catheter dislodgement was inconclusive due to the nature of the returned sample.The product returned for evaluation was two photographs depicting a 20cm powertrialysis acute dialysis catheter.Both photographs depicted the luer adapters, extension tubes, molded joint and a portion of catheter shaft.Blood residue was evident on the shaft.The suture wing was located within the groove on the molded joint in the first photograph and at the 17cm depth marking in the second photograph.While the suture wing was in different positions on the catheter in the two photographs, it could not be determined if that movement occurred while the device was in use or due to device manipulation following removal.Consequently this complaint is inconclusive at this time.
Event or Problem Description
It was reported that at the start of the rn's shift, it was noted the patient's trialysis line was sutured but that the hub wasn¿t sutured and so they attempted to secure it better with stereo strips.It was stated around 0200, the rns were reintubating and positioning the patient and his line became dislodged.The rn went to prepare to push drugs and noticed it was out about an inch and a half from previous location.After removing, rns noted that the suturing adaptor had moved from it¿s original location (picture 1), to further down the line (picture 2).Rn states she doesn't know if it was intentionally sutures that way before but that it created an unsafe situation as the line moved position while cvvhd was running.A new catheter was placed.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (20CM)
• 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: 8441848
• Report Number: 3006260740-2019-00622
• Device Sequence Number: 10869985
• Product Code: NIE
• UDI-Device Identifier: 00801741041952
• UDI-Public: (01)00801741041952
• 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: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 5613200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1