MAUDE Adverse Event Report: COVIDIEN SHORT INSUFFLATION/ACCESS NEEDLE 14 GA; DISPOSABLE SURGICAL ACCESS DEVICE

Catalog Number S110000

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

According to the reporter: during the initial insertion it got broken.Opened another.No pt harm confirmed.Operating time extended: less than 30 min.Tissue damage: yes.Nothing fell into the cavity: no bleeding.

Manufacturer Narrative

(b)(4).

• Brand Name: SHORT INSUFFLATION/ACCESS NEEDLE 14 GA
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3810398
• MDR Text Key: 4526443
• Report Number: 9612501-2014-00105
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S110000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1