MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC.

Catalog Number VASCULAR UNK

Device Problem Positioning Failure (1158)

Patient Problem Laceration(s) (1946)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that prior to use, the resident stuck themselves with the safety scalpel in the kit.They stated the scalpel failed to lock.The resident did not require any stitches or band aids from the incident.

Manufacturer Narrative

(b)(4).The device will not be returned.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL, INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: jody cadd, sr ra specialist ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3853648
• MDR Text Key: 16549974
• Report Number: 1036844-2014-00149
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1