MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOSYN UNDYED 5/0 (1) 70CM DS12 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0023413

Device Problem Battery charger, defective (1054)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).According our client, 1 out of 3 threads breaks at the juncture between needle and thread.

Manufacturer Narrative

Mfg site eval: samples received: 32 unopened pouches.There are no pervious complaint of this code/batch.There are no units in oem stock.All packs received are tight.We have tested the needle attachment of the samples received and the results fulfil the requirements of the oem.Needle attachment results conducted on samples before releasing the product were within spec and fulfilled oem requirements.Reviewed the batch mfg record, this product had a normal process and the results during the process fulfil oem requirements.Final conclusion: the complaint is not corresponding (not justified).Actions on product: na.Corrective/preventive actions: na.

• Brand Name: MONOSYN UNDYED 5/0 (1) 70CM DS12 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; 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: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3880657
• MDR Text Key: 4458867
• Report Number: 2916714-2014-00388
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: C0023413
• Device Catalogue Number: C0023413
• Device Lot Number: 113512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: No
• 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