MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN033048

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "the bleu connector of the venous line was found cracked (see pictures).With this crack, removing the lock ring was an issue because of air suction.The catheter had been inserted 3 months ago." it was reported the catheter was removed and replaced because the patient was "under-dialysis".No patient harm was reported.

Manufacturer Narrative

(b)(4).The customer returned a connector assembly for evaluation.Visual examination revealed the blue (venous) luer hub contained one large crack.The damage appeared consistent with repeated tightening of the luer.The connector assembly was functionally tested by flushing both lumens using a water-filled lab inventory syringe.When the venous line was flushed, water leaked from the cracked luer.No leaks were detected with the arterial line.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the customer report of a cracked luer was confirmed by complaint investigation of the returned sample.The venous (blue) luer contained a large crack, consistent with over-tightening of the luer.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: "the bleu connector of the venous line was found cracked (see pictures).With this crack, removing the lock ring was an issue because of air suction.The catheter had been inserted 3 months ago." it was reported the catheter was removed and replaced because the patient was "under-dialysis".No patient harm was reported.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10591122
• MDR Text Key: 208733326
• Report Number: 9680794-2020-00412
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K111900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: IPN033048
• Device Catalogue Number: CS-15312-SFX
• Device Lot Number: 23F17L0710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention