MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMEND MAX 2/0 (3)70CM HS37S(M)VPL RCP; SYNTHETIC ABSORBABLE MONOFILAR

Model Number 100523590

Device Problems Dull, Blunt (2407); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with monomend max suture.During an unspecified procedure, the suture broke and the needle was blunt.The distributor was also made aware by sales department of other instances of breakage and dullness.No details were known except that veterinarians had voiced some concerns about the suture.Further instructions and reminders to the clinics were issued due to the lack of details; use of the complaint hotline was also reinforced.Additional information was not available.Associated medwatch: 3003639970-2019-00232.

Manufacturer Narrative

Manufacturing site evaluation: analysis and results: there are no previous complaints of the same reference-batch.We have received 1 unopened pack to analyze this case.There are no units in our stock.Tightness test to the closed sample received has been performed and the unit is tight.We have tested the knot pull tensile strength of the closed sample received and the result fulfils the requirements of the european pharmacopoeia (ep).Review of the batch manufacturing record showed this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Knot pull tensile strength results before releasing the product were 3.40 kgf in average and 3.02 kgf in minimum and fulfilled ep requirements.On the other hand, we have checked the needle of the sample received and the aspect is the usual and current one, no defects or damages have been found.However, the needle is tested for needle puncture strength and the penetration performance of the needle is upper to the maximum penetration specification.Despite this result, with only one sample received a suitable analysis cannot be performed in order to take a decision.The average penetration results before releasing the product were 0.475n and 0.614n fulfilling the specification (puncture strength specification: <0.740 n).Final conclusion: although the results of the sample received fulfil the specifications of ep/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.

• Brand Name: MONOMEND MAX 2/0 (3)70CM HS37S(M)VPL RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8550272
• MDR Text Key: 144999102
• Report Number: 3003639970-2019-00358
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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: 100523590
• Device Catalogue Number: 100523590
• Device Lot Number: 117145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Distributor Facility Aware Date: 04/30/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1