MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 90CM HRT37 (M); SUTURES

Model Number G0068651

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Exemption number: (b)(4).Manufacturing site evaluation: samples received: 1 closed box (12 units).Analysis and results: there are no previous complaints of this code-batch.Manufactured (b)(4) units of this code-batch.There are (b)(4) units in stock.Received one closed box.The box label and product is novosyn violet 2/0 (3) 90cm hrt37 (code g0068651 and batch 117314), but the box that contains the product is a safil pre-printed box instead of novosyn pre-printed box.This mistake took place in warehouse when packing the product into the box, the operator took a safil box instead of a novosyn's.Checked the (b)(4) units (2 boxes) in stock and are correct (novosyn pre-printed box).As no other complaints have been received of this code-batch and the boxes in stock are correct, we consider that this is an isolated and accidental box.Nevertheless, note of the incident was taken and the personnel involved has been informed to avoid that this issue happens again.Final conclusion: taking into account that the box 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).The client has received the product with the correct reference number in the box (g0068651), but the denomination is wrong (safil 2/0 hrt37 90 cm).

• Brand Name: NOVOSYN VIOLET 2/0 (3) 90CM HRT37 (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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7520228
• MDR Text Key: 108515650
• Report Number: 3003639970-2018-00309
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/16/2018

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 Expiration Date: 08/03/2022
• Device Model Number: G0068651
• Device Catalogue Number: G0068651
• Device Lot Number: 117314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Distributor Facility Aware Date: 05/04/2018
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/16/2018
• 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