MAUDE Adverse Event Report: COVIDIEN CAPROSYN 4/0 30" UNDYED C-13; SUTURE

Catalog Number SC691

Device Problems Material Separation (1562); Component Missing (2306); Out-Of-Box Failure (2311)

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

Event Date 08/06/2014

Event Type  Injury  

Event Description

Procedure: hernia.According to the reporter: when the suture envelope was opened, it was empty.Some envelopes only contained the thread but not the needle.The sutures what were used on the pt separated from the needle.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: CAPROSYN 4/0 30" UNDYED C-13
• Type of Device: SUTURE
• Manufacturer (Section D): COVIDIEN; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4054106
• MDR Text Key: 15112080
• Report Number: 1219930-2014-00787
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K032586
• 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,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: SC691
• Device Lot Number: B3G0035X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other