MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15122-E

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the dilator did not enter the body well.When the device was removed it was noted that the tip of the dilator was distorted.The procedure was completed using another device.

Manufacturer Narrative

(b)(4).The customer returned one dilator and lid stock.Visual examination revealed the dilator tip is split and folded back.The device contains white coloration, indicating the dilator was under stress.The dilator contained signs of use in the form of biological material on the tip.The length and outer diameter of the dilator were measured and were found to be within specification.The inner diameter of the dilator could not be measured as the tip was damaged.A device history record (dhr) review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" before dilating skin.The customer complaint of a damaged dilator tip was confirmed by complaint investigation.The returned dilator tip was compressed and bent.The tip also contained white stress marks, indicating force caused the damage.A dhr review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample as received and the report that the event happened during use, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the dilator did not enter the body well.When the device was removed it was noted that the tip of the dilator was distorted.The procedure was completed using another device.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6940341
• MDR Text Key: 90077995
• Report Number: 3006425876-2017-00441
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: CS-15122-E
• Device Lot Number: 71F16F1852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1