MAUDE Adverse Event Report: B BRAUN SURGICAL SA NOVOSYN QUICK UN 6/0(0,7)45CM DSMP11MDDP; SUTURES

Model Number C3046607

Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint description: suture has different failures.It was pre operative.Due to this fact, there is no patient, no surgery, tissue or anything else involved.I get 3 samples from the same batch.No 1: thread without the needle.No 2: thread is knotted.No 3.Thread is spliced without a needle.Get no further information an it is not comprehensible when the nurse found the problems.Patient information: not applicable, before use.Samples received: three open pouches.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 our stock.We have received three open samples.One of the samples received has a knot in the thread and can be seen in enclosed picture.This is an isolated and accidental defect that could be produced when the unit is removed from the packaging.We have checked the other two open samples received and we have found the following: one open sample has the needle detached from the thread and thread is still wound on the pack.The other sample is used as has the thread broken and the needle is missing.However, without any closed sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils usp/ep and bbs requirement.Final conclusion: taking into account that the sample received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the sample received.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 "due to this fact there is no patient, no surgery, tissue or anything else involved.I get 3 samples from the same batch.No 2: thread is knotted.Get no further information and it is not comprehensible when the nurse found the problems." all med watch submissions related to this are: 3003639970-2019-00310; 3003639970-2019-00331.

• Brand Name: NOVOSYN QUICK UN 6/0(0,7)45CM DSMP11MDDP
• 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
• MDR Report Key: 8453462
• MDR Text Key: 139961812
• Report Number: 3003639970-2019-00330
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: C3046607
• Device Catalogue Number: C3046607
• Device Lot Number: 118152V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/18/2019
• Device Age: 10 MO
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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