MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 11CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-20854

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the patient was receiving large doses of inotropes.The patient's bp noted to be dangerously low and not increasing with addition of the double strength infusion.It was noted air intermittently present in the clear tubing section of the white cvc proximal port.All infusion lines and connections checked for correct fit and damage, nothing noted.Both inotrope infusions moved to the brown distal cvc port and air continued to be intermittently drawn into clear line of the brown port.All new inotrope infusions made and connected with new lines and new 3-way taps connected back to the white port.Issue resolved.No patient injury reported.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 4-lumen catheter, 60ml syringe and tubing for evaluation.The catheter body was observed to be cut short.Visual examination of the catheter did not reveal any defects or anomalies.The overall length of the catheter body measured 91mm which is not within specification.The catheter body was observed to be cut, most likely during the procedure.The outer diameter of the proximal line and distal line were measured and both were found to be within specification.The returned catheter was tested for liquid leakage.The catheter was attached to the leak tester and the distal end was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks or air were detected from any region of the catheter, including the extension lines; therefore, the sample passed functional testing.All 4 extension lines were tested.The ifu provided with this kit warns the user "do not cut catheter to alter length".The reported complaint of the catheter issue could not be confirmed through examination and functional testing of the returned sample.The returned catheter did not leak during functional testing and met all relevant dimensional and visual requirements.No problem was found with the returned catheter.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the patient was receiving large doses of inotropes.The patient's bp noted to be dangerously low and not increasing with addition of the double strength infusion.It was noted air intermittently present in the clear tubing section of the white cvc proximal port.All infusion lines and connections checked for correct fit and damage, nothing noted.Both inotrope infusions moved to the brown distal cvc port and air continued to be intermittently drawn into clear line of the brown port.All new inotrope infusions made and connected with new lines and new 3-way taps connected back to the white port.Issue resolved.No patient injury reported.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 11CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8808195
• MDR Text Key: 151616759
• Report Number: 3006425876-2019-00507
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K962577
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV-20854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1