MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 2/0 (3) 75CM HR26S CV; SUTURES

Model Number C2095442

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: there are no samples available.Analysis and results: there are two previous complaints of the same reference-batch regarding other issue.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.Final conclusion: complaint is not justified.Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed.Please note that when no samples are received analyzing is very limited.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaints: (b)(6).According to the costumer complaint:"the wire is loose at the needle, not allowing the suture performance.".

Manufacturer Narrative

Samples received: there are no samples available.Analysis and results: there are two previous complaints of the same reference-batch regarding other issue.Manufactured and distributed 1,620 units of this code batch.There are no units in our stock.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.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.Final conclusion: complaint is not justified.Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed.Please note that when no samples are received analyzing is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.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.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.Device not returned.

• Brand Name: PREMILENE 2/0 (3) 75CM HR26S CV
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 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: 5582615
• MDR Text Key: 42851430
• Report Number: 2916714-2016-00272
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K980703
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2095442
• Device Catalogue Number: C2095442
• Device Lot Number: 112401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2016
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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