MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12853

Device Problem Complete Blockage (1094)

Patient Problem Death (1802)

Event Date 12/18/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).At this time the customer cannot confirm if the alleged issue with the device caused or contributed to the outcome of the patient's death.

Event Description

It was reported that: whilst the dialyze was plugged in, using the push syringes plugged on the proximal lines, the alarm of these push syringes rang.The message was indicating a blockage of this line with consequences for the patient to have its tension pressure falling.Clinical consequences: the patient could not get its treatment (catecholamines).So, another central venous line was inserted in urgency to find a temporary solution connecting the catecholamines on the distal line to have the tension getting up.

Manufacturer Narrative

(b)(4).The customer returned one three-lumen cvc for evaluation.Visual inspection was performed, and biological material was observed inside the catheter body near the distal tip.No other defects or anomalies were observed.A dimensional inspection was also performed and the sample met all relevant dimensional requirements.A lab inventory ars syringe was used to pass water through all three extension lines.The water was able to pass with little difficulty.No blockages were observed.A leak test was performed on all three extension lines.With the body of the catheter occluded, a lab inventory syringe was used to inject water through each lumen.No leaks were observed.A straight wire with a diameter of.032" was inserted through the distal and proximal end of the three extension lines.No significant resistance or blockages were observed for any of the lumens.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit, warns the user that after inserting the catheter, "flush lumen(s) to completely clear blood from catheter." the ifu also cautions, "do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Air embolus can occur with these practices." the customer reported issue of a blockage in one of the extension lines was not confirmed during the sample investigation.Visual and functional inspections were performed, and no issues were identified.The sample met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: whilst the dialyze was plugged in, using the push syringes plugged on the proximal lines, the alarm of these push syringes rang.The message was indicating a blockage of this line with consequences for the patient to have its tension pressure falling.Clinical consequences: the patient could not get its treatment (catecholamines).So, another central venous line was inserted in urgency to find a temporary solution connecting the catecholamines on the distal line to have the tension getting up.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• 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: 8261753
• MDR Text Key: 133560268
• Report Number: 3006425876-2019-00001
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: 12/24/2018

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: No Information
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F18G1969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• 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): Death