MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 2/0 (3) 150CM HR26 (M); SUTURES

Model Number B0041444

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 11 unopened pouches and 1 opened pouch.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed (b)(4) units of this code batch.There are no units in stock.Received eleven closed samples and one open sample (only the second pack is open).The first pack (aluminum pouch) on the open sample received is not sealed/glued to the peel foil.Opened all closed packs received and the aluminum pouch was not stuck to the outer paper foil.All packs have been opened correctly.Defective samples are needed to show the defect to asses properly the customer complaint.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.The results of the samples received fulfill the oem specifications.Note is taken of this incident in order to assess if new or additional actions are needed.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

Country of complaint: (b)(6).It was reported that the first pack was sealed to the second pack.

• Brand Name: MONOMAX VIOLET 2/0 (3) 150CM HR26 (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: 6201182
• MDR Text Key: 63611887
• Report Number: 3003639970-2016-00025
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: B0041444
• Device Catalogue Number: B0041444
• Device Lot Number: 115511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Distributor Facility Aware Date: 12/12/2016
• Date Manufacturer Received: 11/23/2016
• 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