MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 75CM HS26 .; SUTURES

Model Number G0712418ESV

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 3 boxes that contain 12 units each box.Analysis and results: there are no previous complaints of this code batch.Manufactured 720 units of this code batch.There are 48 units in stock.Received three boxes from the customer where the box label and the product match perfectly (supramid), but the pre-printed box is wrong (dafilon).Reviewed all boxes in stock (33 boxes) at the moment of receiving the complaint and we have found three boxes (of these 33 boxes checked) with the same defect.This mistake took place at the moment of selection of pre-printed box of the product in the warehouse.The person who was re-conditioning the product manually, selected a wrong pre-printed box.Final conclusion: taking into account that the samples received do not fulfill the oem specifications, it is concluded that the complaint is justified.Corrective/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).It was reported that mix-up: wrong pre-printed box.

• Brand Name: SUPRAMID BLACK 3/0 (2) 75CM HS26 .
• 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: 7217052
• MDR Text Key: 98295922
• Report Number: 3003639970-2018-00062
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: G0712418ESV
• Device Catalogue Number: G0712418ESV
• Device Lot Number: 617383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Distributor Facility Aware Date: 01/22/2018
• Date Manufacturer Received: 01/09/2018
• 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