MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 16 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-12802

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Physical Resistance (2578)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).Additional information requested, but not received at the time of this report.

Event Description

The customer reports that a patient with a tunneled vcv, placed in a chinstrap, on (b)(6) 2017.At the point of entry a little blood was observed.When irrigating with a 20cc syringe at the point of entry there is slight resistance.Light amount of blood then flows from the puncture point of the cvc.The medical staff decided not to give lovenox again.The line was monitored to give the day's medicines.Later in the day, there was an area of colorless liquid on the bed and patient was wet at the neck area.The medicines appear to emerge through the entry point.The cvc itself seemed a bit out (2.5cm).A metal part is visible.A pvc was inserted.The cvc was left in place and the cvc line was plugged/sealed.The metal part is no longer in the patient, but out.The plastic tubing is still in the patient.The patient is sent to the resuscitation for monitoring and sent to radiology to remove the cvc.Intervention - surgical and radiological intervention to remove the device.

Manufacturer Narrative

Qn#(b)(4).The customer returned one piece of a catheter body.Visual examination revealed that the entire catheter piece is white including the distal tip.The catheter has black markings from 5 to 20cm with 5cm marking being closest to the distal tip.Microscopic examination revealed the proximal end has an uneven/jagged edge with additional cut marks indicating that it was cut to separate from the rest of the catheter.The returned catheter has a single lumen.The returned piece measured 23cm long.A review of the catheter graphic for the reported kit confirmed that the returned catheter piece is not from the reported kit.The catheter in the reported kit is a 2 lumen 16cm catheter with a blue flex tip and markings to 15cm.A device history record (dhr) review was performed on the catheter with no relevant findings.Complaint verification testing could not be performed because an incorrect sample was returned for analysis.The customer reported the event occurred with a 2 lumen 16cm catheter with a blue flex tip and the catheter piece that was returned was from a single lumen catheter of at least 20cm and a white tip.Other remarks: the dhr review performed did not reveal any manufacturing related issues.The probable cause of the catheter leak and separation could not be determined based upon the information provided and without the correct sample.

Event Description

The customer reports that a patient with a tunneled vcv, placed in a chinstrap, on (b)(6) 2017.At the point of entry a little blood was observed.When irrigating with a 20cc syringe at the point of entry there is slight resistance.Light amount of blood then flows from the puncture point of the cvc.The medical staff decided not to give lovenox again.The line was monitored to give the day's medicines.Later in the day, there was an area of colorless liquid on the bed and patient was wet at the neck area.The medicines appear to emerge through the entry point.The cvc itself seemed a bit out (2.5cm).A metal part is visible.A pvc was inserted.The cvc was left in place and the cvc line was plugged/sealed.The metal part is no longer in the patient, but out.The plastic tubing is still in the patient.The patient is sent to the resuscitation for monitoring and sent to radiology to remove the cvc.Intervention - surgical and radiological intervention to remove the device.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 16 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: 6518392
• MDR Text Key: 73603352
• Report Number: 3006425876-2017-00137
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CS-12802
• Device Lot Number: 71F16L1185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 55