MAUDE Adverse Event Report: RROW INTERNATIONAL, INC. CVC SET: 16 GA X 8" (20CM); SINGLE LUMEN CVC PRODUCTS

Catalog Number ES-04301

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that in the micu, the md found that the connection between the ars and introducer needle was too loose to use.As a result, a new kit was opened and used without issue to successfully complete the procedure.There was no reported delay, death, or complications to the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: CVC SET: 16 GA X 8" (20CM)
• Type of Device: SINGLE LUMEN CVC PRODUCTS
• Manufacturer (Section D): RROW INTERNATIONAL, INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE MEXICO, S.A. DE C.V.; modulo 1, circuito 5; parque industrias de america; col. panamericana, chihuahua 3120 0; MX 31200
• Manufacturer Contact: alice harper ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4288989
• MDR Text Key: 5194804
• Report Number: 9680794-2014-00180
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ES-04301
• Device Lot Number: CF1011799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2011
• 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