MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 2/0 (3) 70CM HR26 (M); SUTURES

Model Number C0022026

Device Problems Out-Of-Box Failure (2311); Detachment of Device or Device Component (2907)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The needle was detached from the thread in the package before use.

Manufacturer Narrative

Samples received: 1 open unit.Analysis and results: there are no previous complaints of this code batch of which 6,048 units were manufactured and distributed in the market.There are no units in stock in b.Braun surgical warehouse.We have received an open and unused sample with the needle detached from the thread.The thread looks like it has escaped from the needle, nevertheless without closed samples a proper analysis cannot be done.Taking into account that there are no other customer complaints concerning this issue for this code batch we consider that this is an isolated unit.Moreover, reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils usp/ep and b.Braun surgical requirements.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyze it.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: MONOSYN VIOLET 2/0 (3) 70CM HR26 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7068893
• MDR Text Key: 93724305
• Report Number: 3003639970-2017-00572
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0022026
• Device Catalogue Number: C0022026
• Device Lot Number: 117086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/20/2017
• Date Manufacturer Received: 11/06/2017
• 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