MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOMAX VIOLET 1(4) 200CM HRT48 LOOP(M; SYNTHETIC SUTURE

Model Number B0041231

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Monomax loop tore during suture of abdominal wall.There were two cases reported in the hospital with this code/batch.One x general surgery.One x urology.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 1 unopened pouch.There are no previous complaints of this code batch.No units in oem stock.Tightness test to sample received has been performed and the unit is tight.Tested the knot pull tensile strength of the sample received and the result fulfills the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled oem requirements.Actions on product: not applicable.Corrective/preventive actions: not applicable.

• Brand Name: MONOMAX VIOLET 1(4) 200CM HRT48 LOOP(M
• Type of Device: SYNTHETIC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) ; SP
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4647848
• MDR Text Key: 5601109
• Report Number: 2916714-2015-00247
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122734
• 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: 03/23/2015

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: 09/01/2019
• Device Model Number: B0041231
• Device Catalogue Number: B0041231
• Device Lot Number: 114371
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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