MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC TWO-LUMEN/PSI KIT: 9 FR X 11.5 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-11242-KSF

Device Problem Defective Component (2292)

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

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the returned device indicates dilator tip damaged found during use.

Event Description

The customer reports that the tip of the dilator was frailed.

Event Description

The customer reports that the tip of the dilator was frailed.

Manufacturer Narrative

(b)(4).The customer returned one, assembled, two-lumen central venous access catheter and a lidstock for evaluation.Visual examination of the dilator revealed that the tip was damaged.The dilator tip showed signs of use in the form of dried blood.Microscopic examination revealed that the dilator was split in one location around the circumference of the tip.The circumference of the tip was slightly flared outward and white discoloration was found along the split , indicating stress.The dilator length from the distal end of the hub to the dilator tip measured 8 13/16", which matches the specification of 8 12/16"-8 14/16", per dilator product drawing.The dilator inner and outer diameter were also within specification.A device history record review was performed and no relevant findings were found to suggest a manufacturing issue.The ifu provided with the kit was also reviewed as part of this complaint investigation.It instructs the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" prior to dilator insertion.The reported complaint that the dilator tip was damaged during use was confirmed through complaint investigation.The tip of the dilator was cracked with discoloration around the edges, indicating that it had undergone stress.A device history record review was performed and no relevant findings were found to suggest a manufacturing issue.Based on the condition of the returned sample and the customer report , it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MAC TWO-LUMEN/PSI KIT: 9 FR X 11.5 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8080913
• MDR Text Key: 127551836
• Report Number: 1036844-2018-00296
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: ASK-11242-KSF
• Device Lot Number: 23F18B0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1