MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS C VIOLET 2/0 (3) 25M; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number F0024272

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported an issue with monoplus c suture.The client (veterinarian) reported that the suture from cassette keeps snapping making it unusable.The cassette was purchased on the (b)(6) 2022 and opened for use on (b)(6) 2022.No more information has been provided.

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Under pma/510(k) number: k031216.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received one open and used cassette with the date of cassette's opening written: (b)(6) 2022.The case occurred on (b)(6) 2022, so the suture was used within 4 months period after opening, which is correct.However, the reception of the cassette was on (b)(6) 2022, few days after these 4 months period after opening.We have tested the knot pull tensile strength of the thread of the cassette received and the results do not fulfil the requirements of the european pharmacopoeia (ep).Thread in the cassette received breaks easily, the thread is degraded.Thread degrades by hydrolysis because of air humidity.Stability tests performed guarantee product properties within 4 months after opening the cassette.Reviewed the manufacturing record of the batch, this product had a normal process and no deviations have been reported during the manufacturing process.Although the cassette has been received only a few days after these 4 months period after opening, we consider that the complaint is confirmed and concerns only this cassette as no other customer complaints have been received for this code-batch.The probable cause of the malfunction could be an excess of humidity causing a weakening of the thread strength of the complained unit, once the cassette has been opened.As indicated on the cassette label, store at room temperature.Avoid exposure to extreme temperatures over a long period of time.Final conclusion: taking into account that the results of cassette received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed.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.You will receive a credit note for one cassette as compensation.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: MONOPLUS C VIOLET 2/0 (3) 25M
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 15063396
• MDR Text Key: 298311375
• Report Number: 3003639970-2022-00299
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2022
• Device Model Number: F0024272
• Device Catalogue Number: F0024272
• Device Lot Number: 121255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2021
• 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