MAUDE Adverse Event Report: B BRAUN SURGICAL SA CATGUT CHROM 3/0 (3) 75CM HR26; SUTURE

Model Number B0560421

Device Problem Packaging Problem (3007)

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

Event Date 02/16/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The envelope of the suture is leaking fluid.The lot is years before the improvements.

Manufacturer Narrative

One sample rec'd for investigation.There are no units in stock.The database was reviewed claims and evidence that we have a report related to this prod code and batch number and causes, from the mfg of this (2012).Batch record reviewed and no deviations found.Review of batch release documents showed no deviations.The sample rec'd was subjected to a visual examination where it is evident that the suture is without sterilizing solution, this is due to a fault during the mfg process, which can not be identified at the time of prod release.Despite that have already taken action in this regard, the lot number was mfg before having implemented process improvements.Corrective action previously implemented at oem.

• Brand Name: CATGUT CHROM 3/0 (3) 75CM HR26
• Type of Device: SUTURE
• Manufacturer (Section D): B BRAUN SURGICAL SA; rubi, barcelona 0819 1; SP 08191
• Manufacturer (Section G): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 0819 1; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert point dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4674032
• MDR Text Key: 5735064
• Report Number: 2916714-2015-00297
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0560421
• Device Catalogue Number: B0560421
• Device Lot Number: 512505
• Date Manufacturer Received: 03/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other