MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the procedure was being performed in the emergency department.The physician placed the catheter in the patient's subclavian and it was sutured at the fastener and clamp.Upon transporting the patient, the central line slipped out of the clamp and fastener.As a result an io product was used.They do not know if this caused a delay in treatment and there was no patient death or complications reported.It was noted the physician has had many years of experience placing central lines.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5430533
• MDR Text Key: 38650971
• Report Number: 1036844-2016-00119
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15A1131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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