MONOMAX VIOLET 0 (3,5) 70CM FR26 (M) B0041888

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-14 for MONOMAX VIOLET 0 (3,5) 70CM FR26 (M) B0041888 manufactured by B. Braun Surgical Sa.

Event Text Entries

[128400486] (b)(4). Manufacturing site evaluation: samples received: there are no samples available. Analysis and results - there are no previous complaints nor units in our stock for the two possible batches (118181 and 118263). Without a sample, we cannot carry out a complete analysis. Nevertheless, we have tested the bending strength of needles available in stock of the same needle raw material batches, and the results fulfill the specification for these needles. In reviewing the batch manufacturing records of these products, there were no incidents related to these issues and the results during the process fulfilled requirements. Remarks: when working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders. Care should be taken to avoid damaging the needle when using the suture material. Always grasp the needle in a section 1/3 to 1/2 of the distance from the fiber attachment end to the needle point, and never at the end where the fiber is attached or the needle point. Grasping the needle at the area of its point could impair the penetration performance and cause a fracture of the needle. Grasping the needle close to the fiber attachment end could cause bending or breakage. Reshaping needles should be avoided and may result in a loss of their strength and resistance towards bending and breaking. Final conclusion - no samples were provided and testing could not be performed. Nevertheless, we take note of this incidence and if any sample is received in the future, the case will be re-opened and the product further analyzed.
Patient Sequence No: 1, Text Type: N, H10


[128400487] It was reported that several times the sutures have broken during an operation causing longer operation time. It was noted that one case involved a c-section. Sometimes needles are broken and sometimes the inner package has stuck to the outer package. This report addresses the sutures that had broken. Additional information was not provided. All medwatch submissions related to this report are: 3003639970-2018-00737; 3003639970-2018-00738.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003639970-2018-00717
MDR Report Key8070877
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-11-14
Date of Report2018-11-14
Date of Event2018-10-17
Date Facility Aware2018-10-18
Date Mfgr Received2018-10-18
Date Added to Maude2018-11-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1B. BRAUN SURGICAL SA
Manufacturer Street121 CARRETERA DE TERRASSA
Manufacturer CityRUBI, 08191
Manufacturer CountrySP
Manufacturer Postal Code08191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONOMAX VIOLET 0 (3,5) 70CM FR26 (M)
Generic NameSYNTHETIC ABSORBABLE MONOFILAR
Product CodeNWJ
Date Received2018-11-14
Model NumberB0041888
Catalog NumberB0041888
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN SURGICAL SA
Manufacturer Address121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-14

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