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

Catalog Number CS-12853-E

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pneumothorax (2012)

Event Date 12/27/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Potential lot numbers: 71f18k0103, 71f18j2296, 71f18h1770.Pneumothorax classified as iatrogen pneumothorax.To date, the user facility does not indicate if the alleged issue with the device caused or contributed to the patient's death.Investigation: the customer report of incorrect needle dimensions could not be confirmed from evaluation of the returned sample.The customer returned a needle that dimensional and visual examination revealed was the 20ga needle from the catheter-over-needle assembly.No defects or anomalies were observed with the needle and it met all relevant dimensional requirements.An 18ga introducer needle is also supplied in this set which was not returned by the customer.The ifu supplied with this product details the differences in technique when using the catheter-over-needle and the 18ga introducer needle.Other remarks: a device history record was performed based on sales history review and no relevant issues were identified.Based on the returned needle, no problem was found with the sample.Teleflex will continue to monitor, and trend reports of this nature.Corrective action is not required as no problem was found with the sample returned by the customer.

Event Description

The customer reports the needle is thinner and longer than usual.Clinical consequence: a major pneumothorax.

Manufacturer Narrative

(b)(4).Additional information was received from the customer.The customer reports that the needle contributed to the pneumothorax that the patient sustained and that the device caused or contributed to the patient death.They also reported "the needle used for the puncture of the vein was not in the kit.The only needle in the kit was the long and thin needle without the catheter.It's this needle that caused the pneumothorax".Although the customer reports that the device caused or contributed to the patient death, the complaint of incorrect needle dimensions could not be confirmed from evaluation of the returned sample.The customer returned a needle that dimensional and visual examination revealed was the 20ga needle from the catheter-over-needle assembly.No defects or anomalies were observed with the needle and it met all relevant dimensional requirements.An 18ga introducer needle is also supplied in this set which was not returned by the customer.The ifu supplied with this product details the differences in technique when using the catheter-over-needle and the 18ga introducer needle.Other remarks:.

Event Description

The customer reports the needle is thinner and longer than usual.Clinical consequence: a major pneumothorax.

• 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: 8290194
• MDR Text Key: 134510596
• Report Number: 3006425876-2019-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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 Catalogue Number: CS-12853-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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; Other