MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 4/0 (1.5)70CM HR17 (M)

Model Number C0068013

Device Problems Failure To Adhere Or Bond (1031); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open pouch.Analysis and results: there are two possible batches affected: 115256 or 115343.(b)(4) units of the batch 115256 and (b)(4) units of the batch 115363 were manufactured and distributed.There are no units in stock of any of them one open sample was received with the needle detached from the thread and the thread is unused.Without any closed sample an analysis cannot be carried out to make a decision.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.In spite of receiving a defective sample, without a closed samples a suitable analysis cannot be performed.Note of this incidence will be made, and if any closed sample is received in the future, the case will be re-opened and analysed.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 complaint: (b)(6).The needle was already loose when opening the package.The customer had to look for the needle.

• Brand Name: NOVOSYN VIOLET 4/0 (1.5)70CM HR17 (M)
• Type of Device: NOVOSYN
• 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: 5383940
• MDR Text Key: 36587298
• Report Number: 2916714-2016-00015
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122734
• 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
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068013
• Device Catalogue Number: C0068013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Distributor Facility Aware Date: 01/08/2016
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/21/2016
• 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