MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 5/0(1)70CM 2XDR13B(M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number C0024224

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Year of birth - (b)(6) (date and month unknown).(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 monoplus.A pancreatico-duodenectomy with distal gastric resection was performed.Six days later, the patient had to undergo a second surgery for bilio-digestive anastomosis.It was noted that the suture had broken from the original procedure; continuous suture technique had been employed with knots.The color of the monoplus was also not visible.The surgeon stated that the possible cause of the malfunction was that the tensile strength was too low.The patient outcome after the revision was good.Additional information was not provided.

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: e2014012.Investigation: samples received: 36 unopened pouches.Analysis and results: there are no previous complaints of the same reference-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received 36 closed samples from the customer.Tightness test to the samples received has been performed and the units are tight.We have tested the knot pull tensile strength of all samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.88 kgf in average and 0.80 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).Moreover, degradation test results conducted on the samples received fulfil b.Braun surgical (bbs) requirements.In the degradation test, threads are introduced in a sörensen solution at 37ºc for 28 days.After this period, the knot pull tensile strength of the thread is tested.The results for the samples received are 0.82 kgf in average and 0.65 kgf in minimum (bbs requirements: 0.51 kgf in average and 0.34 kgf in minimum).Additionally, we have also tested the linear pull tensile strength of the samples received and the results are: 1.03 kgf in average and 0.85 kgf in minimum (bbs requirement: 0.51 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Dyestuff content of monoplus 5/0 raw material fulfilled the specifications of the product.Monoplus is colored violet with the dyestuff d&c violet no.2, that is approved by the fda for monofilament sutures.On the other hand, we can see the loss of color in the thread after incubating the thread in sörensen solution used to conduct the degradation test after 28 days (as can be seen in enclosed picture), but this is the typical behavior for this suture.This discoloring effect has neither influence in the suture strength properties nor clinical effect in the tissues sutured with monoplus.Final conclusion: according to the results of the samples tested and the batch manufacturing record review, the product complies with our specifications and also fulfil usp/ep requirements.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

• Brand Name: MONOPLUS VIOLET 5/0(1)70CM 2XDR13B(M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8562636
• MDR Text Key: 143535892
• Report Number: 3003639970-2019-00381
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: C0024224
• Device Catalogue Number: C0024224
• Device Lot Number: 117415V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Distributor Facility Aware Date: 05/27/2019
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention