MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW THORACENTESIS KIT; CATHETER AND TIP, SUCTION

Catalog Number AK-01000

Device Problems Material Deformation (2976); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the catheter was in the patient, and when the user hooked it up to the vacuum device it would not flow.Upon examination of the tubing, it was defective with appearance of being "melted" or pinched which did not allow fluid to flow.The catheter was changed to different tubing from the same kit which also had a defective portion (second device documented in mdr # 3003737899-2017-00119).The user was able to work around the defective tubing and continue the procedure.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as a lot number was not provided by the customer.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 customer alleges that the catheter was in the patient, and when the user hooked it up to the vacuum device it would not flow.Upon examination of the tubing, it was defective with appearance of being "melted" or pinched which did not allow fluid to flow.The catheter was changed to different tubing from the same kit which also had a defective portion (second device documented in mdr # 3003737899-2017-00119).The user was able to work around the defective tubing and continue the procedure.

• Brand Name: ARROW THORACENTESIS KIT
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6947994
• MDR Text Key: 90310372
• Report Number: 3003737899-2017-00118
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

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: AK-01000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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