MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM; CATHETER HEMODIALYSIS IMPLANTE

Model Number	IPN033108
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reported when removing the catheter, the cuff was no longer attached to the catheter.The physician was changing out the catheter and usually does dissection between the cuff and the tissues.In this case not much dissection had to be done and the catheter was clean with no residue of the cuff left on it.It was unknown if the cuff was left in the patient's body.The cuff was never found.The catheter was placed on (b)(6) 2020 and removed (b)(6) 2021.Catheter worked with no issues during that time.No medical intervention was required.No imaging was performed on patient to look for cuff.No patient harm was reported.The new catheter was placed without incident.
Event or Problem Description
Customer reported when removing the catheter, the cuff was no longer attached to the catheter.The physican was changing out the catheter and usually does dissection between the cuff and the tissues.In this case not much dissection had to be done and the catheter was clean with no residue of the cuff left on it.It was unknown if the cuff was left in the patient's body.The cuff was never found.The catheter was placed on (b)(6) 2020 and removed (b)(6) 2021.Catheter worked with no issues during that time.No medical intervention was required.No imaging was performed on patient to look for cuff.No patient harm was reported.The new catheter was placed without incident.
Additional Manufacturer Narrative
(b)(4).The customer returned one chronic hemodialysis catheter for analysis.Signs-of-use in the form of biological material was observed on the catheter body.The separated cuff was not returned for analysis.Visual analysis revealed that the catheter cuff on the catheter body was no longer present on the assembly.Microscopic examination revealed remnants of the cuff in the form of adhesive residue on the catheter body.No other defects or anomalies were observed.The catheter body length measured 22.75cm, which is within the specification limits of 20cm-26cm.The catheter body outer diameter measured.2065", which is within the specification limits of.2010"-.2070" per the catheter body extrusion graphic.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "cut catheter between clamp and exit site, remove internal portion of catheter through cuff incision site.Check catheter integrity for tears.Measure catheter when removed; it must be equal to length of catheter when inserted.Inspect for entire cuff".The reported complaint of a catheter cuff separating from the catheter body was confirmed by complaint investigation.The catheter cuff was not returned.The catheter body extrusion contained adhesive material at the location of the cuff.This indicates that manufacturing correctly assembled the cuff to the extrusion.No other anomalies or abnormalities were observed.A device history record review was performed, and no relevant findings were identified.Based on the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11913948
• Report Number: 9680794-2021-00260
• Device Sequence Number: 19683074
• Product Code: MSD
• UDI-Device Identifier: 20801902096634
• UDI-Public: 20801902096634
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 02/28/2023
• Device Model Number: IPN033108
• Device Catalogue Number: CSD-15282-SP
• Device Lot Number: 13F20C0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.