MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 1(4)150CM HR48 LOOP(M); SUTURES

Model Number B0041119

Device Problems Product Quality Problem (1506); Difficult to Open or Remove Packaging Material (2922)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the threads are sticky and therefore it is difficult to remove the out of the primary package.

Manufacturer Narrative

Samples received: 16 unopened and 1 opened pouches.Analysis and results: there are no previous complaints of this batch.We manufactured and distributed in the market 1,080 units of this batch.There are no units in stock.We have received 16 closed samples and one open sample (only the second pack is open).Tightness test to the closed samples received has been performed and the units are tight.Extraction of the suture in the received samples is correct and the current one.Suture has been pulled out without difficulty and does not become tangled.We have checked carefully all samples received and no defects or irregularities have been found.Thread surface on the samples received is correct and the usual one.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b.Braun surgical requirements.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 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: MONOMAX VIOLET 1(4)150CM HR48 LOOP(M)
• 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: 6378641
• MDR Text Key: 69097307
• Report Number: 3003639970-2017-00107
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100876
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: B0041119
• Device Catalogue Number: B0041119
• Device Lot Number: 116373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/23/2017
• Date Manufacturer Received: 02/03/2017
• 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