MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 4FR X 8CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15403

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Swelling/ Edema (4577)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: device: "triple 8cm arrow device of unknown product code or lot number" complaint: "more recently we've been forced to use the triple 8cm arrow which has a clamp to position it at variable length at the skin; we've had several extravasations relating to the line slipping in the clamp.Many of the problems occur in complex, small, and often edematous babies".Attempt for additional information to the customer has been unsuccessful.Unknown when incident was first observed and if any intervention was required.Patient condition unknown at time of report.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: device: "triple 8cm arrow device of unknown product code or lot number." complaint: "more recently we've been forced to use the triple 8cm arrow which has a clamp to position it at variable length at the skin; we've had several extravasations relating to the line slipping in the clamp.Many of the problems occur in complex, small, and often edematous babies".Attempt for additional information to the customer has been unsuccessful.Unknown when incident was first observed and if any intervention was required.Patient condition unknown at time of report.

• Brand Name: ARROW CVC SET: 3-LUMEN 4FR X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12177509
• MDR Text Key: 261953169
• Report Number: 3006425876-2021-00636
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 06/23/2021

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
• Device Operator: No Information
• Device Catalogue Number: CS-15403
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.