MAUDE Adverse Event Report: B BRAUN SURGICAL SA PREMILENE 2/0 (3) 75CM GS60 (M) .RCP; POLYPROPYLENE SUTURE

Model Number C2090266

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle detached / loose.

Manufacturer Narrative

Us reporting agent notification received: (b)(6) 2014.Needle detached / loose.Loose / detached needle noticed upon opening of the package.Samples received: (b)(6) open units.Failure analysis: evaluation on-going as of the date of this report.

• Brand Name: PREMILENE 2/0 (3) 75CM GS60 (M) .RCP
• Type of Device: POLYPROPYLENE SUTURE
• Manufacturer (Section D): B BRAUN SURGICAL SA; 121 carretera de terrassa
• Manufacturer (Section G): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4368150
• MDR Text Key: 5112497
• Report Number: 2916714-2014-01018
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: C2090266
• Device Catalogue Number: C2090266
• Device Lot Number: 113435
• Other Device ID Number: 10
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/17/2014
• 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
• Patient Outcome(s): Other