MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. CATGUT CHROM 5/0 (1.5) 75CM HR17; CATGUT SUTURE

Model Number B0560138

Device Problems Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: fluid leak in the package; contamination and makes the suture dehydrated.

Manufacturer Narrative

Us reporting agent notified on: (b)(6) 2014.Mfg site evall eval is ongoing.

• Brand Name: CATGUT CHROM 5/0 (1.5) 75CM HR17
• Type of Device: CATGUT SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle ling ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3155515938
• MDR Report Key: 4147329
• MDR Text Key: 4766769
• Report Number: 2916714-2014-00707
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K991223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0560138
• Device Catalogue Number: B0560138
• Device Lot Number: 512032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2014
• 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