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

Model Number C0024026

Device Problems Failure To Adhere Or Bond (1031); Component Missing (2306)

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

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that in some cases of the monoplus sutures the needle is missing and/or some of the needles are detached from the thread at the opening of the package.

Manufacturer Narrative

Samples received: 1 support cardboard with a suture.Analysis and results: we have received an open and used sample, only a support cardboard and a thread, there is no aluminium pack.Thread is detached from the needle, needle is missing.There are marks in the thread that a needle was attached, nevertheless in the support cardboard there are no needle marks.It could be possible that the needle was attached to the thread but it detached in the package.However, without batch number or list of possible batches further analysis cannot be done.Batch manufacturing records cannot be checked.Final conclusion: without closed samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.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.

• Brand Name: MONOPLUS 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: 6674881
• MDR Text Key: 78658014
• Report Number: 3003639970-2017-00346
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031216
• 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: 07/07/2017

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: C0024026
• Device Catalogue Number: C0024026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/27/2017
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 06/19/2017
• Supplement Dates FDA Received: 07/07/2017
• 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