MAUDE Adverse Event Report: B. BRAUN SURGICAL SA FLEXOCRIN 4/0 (1.5) 90CM DS19; SUTURES

Model Number C0865320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: date of event: unknown.Samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed 1,980 units in the market.There are no units in stock in the warehouse.Received an open and unused sample with the needle detached from the thread and the thread still wound on the pack.Taking into account that no other complaints have been received concerning this issue, for this code batch we consider that this is an isolated unit.Final conclusion: in spite of receiving a defective sample, without a closed samples a suitable analysis cannot be performed.Nevertheless, note of this incident is taken and if any closed sample is received in the future, the case will be re-open and analyzed.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.

Event Description

It was reported by the healthcare professional to the company sales representative "at the opening of the package, the thread is no longer attached into the needle: impossibility of use." no harm to patient reported.

• Brand Name: FLEXOCRIN 4/0 (1.5) 90CM DS19
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7908024
• MDR Text Key: 121714535
• Report Number: 3003639970-2018-00619
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: C0865320
• Device Catalogue Number: C0865320
• Device Lot Number: 617264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2018
• Date Manufacturer Received: 08/28/2018
• 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