MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL CATH SET: 20 GA X 3-1/16"; ARTERIAL CATHETER PRODUCTS

Catalog Number GH-04125

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 04/13/2014

Event Type  malfunction  

Event Description

An anesthetist-resuscitator reports that it was impossible to remove the swg.Clinical consequences: delay in diagnosis, lack of supervision in arterial blood pressure.

Manufacturer Narrative

(b)(4).

• Brand Name: ARTERIAL CATH SET: 20 GA X 3-1/16"
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; chihuahua 3120 0; MX 31200
• Manufacturer Contact: jody cadd, sr. specialist ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3915358
• MDR Text Key: 4582229
• Report Number: 9680794-2014-00113
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: GH-04125
• Device Lot Number: 14F13L0277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1