MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOSYN UNDYED 4/0 (1.5) 70CM DS19 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0023404

Device Problem Battery charger, defective (1054)

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

Event Date 02/28/2014

Event Type  malfunction  

Event Description

Country of complaint; (b)(6).Suture breaks easily during knotting.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Samples received: no samples available.There are no previous complaints of this code batch were manufactured and distributed, no units remain in oem stock.Without any closed and/or defective sample we cannot carry out an analysis.Reviewed the batch manufactured and distributed, no units remain in oem stock.Without any closed and/or defective sample we cannot carry out an analysis.Reviewed the batch manufacturing 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: not applicable.Corrective/preventative actions: not applicable.

• Brand Name: MONOSYN UNDYED 4/0 (1.5) 70CM DS19 (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 S.A.; 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: 3877202
• MDR Text Key: 21965434
• Report Number: 2916714-2014-00358
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K013375
• 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: 05/19/2014

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 Model Number: C0023404
• Device Catalogue Number: C0023404
• Device Lot Number: 1133595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/19/2014
• 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
• Patient Outcome(s): Other