MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 45CM HS21; SUTURES

Model Number C0712256

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the package was labeled (b)(4) but the inside product was labeled (b)(4).The wrong product was inside the box.

Manufacturer Narrative

Samples received: 1 unopened box (36 pouches).Analysis and results: there are no previous complaints of this batch.Manufactured and distributed in the market (b)(4) units of this batch.There are no units in stock.Received 1 closed box.The box label and product is supramid black 4/0 (1.5) 45cm hs21 (code c0712256 and batch 616466) but the box that contains the product is a dafilon pre-printed box.This mistake took place in production area when packing the product into the boxes, the operator took a dafilon box instead of a supramid's.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.Nevertheless, the storage locations of the pre-printed boxes will be rearranging to avoid this defect and bin identification labeling will be changed to improve visibility.

• Brand Name: SUPRAMID BLACK 4/0 (1.5) 45CM HS21
• 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: 6358889
• MDR Text Key: 68362416
• Report Number: 3003639970-2017-00071
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: C0712256
• Device Catalogue Number: C0712256
• Device Lot Number: 616466V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/06/2017
• Date Manufacturer Received: 01/26/2017
• 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