MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 2/0 (3) 6X45CM; SUTURES

Model Number B0436534

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that two boxes of sutures had the incorrect label on it.The boxes was labeled b0436534 instead of 0617135.

Manufacturer Narrative

Samples received: 2 open box with 12 unopened long-packs.Analysis and results: there are no previous complaints of any of the two involved products in the complaint.(b)(4), there are no units in b.Braun surgical warehouse.We have received two boxes which contain 12 units each.All units are of the reference-batch g0617135 (steelex sternum set 5)- (b)(4).The box label corresponds to the reference-batch b0436534 (dafilon 2/0)- (b)(4).Products traceability has been checked and it has been determined that this mix-up took place at the moment of preparing the shipment in the warehouse.The operator took by mistake one steelex sternum set boxes and labeled it with the dafilon label.Moreover, it was not correctly checked that the product inside and product label were correct.We conclude that there are no more boxes affected.Final conclusion: taking into account that the box received does not fulfill b.Braun surgical specifications, we conclude that the complaint is justified.Actions on distributed product 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 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.Moreover, activities have been proposed in order to avoid this issue to happen.

• Brand Name: DAFILON BLUE 2/0 (3) 6X45CM
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6635181
• MDR Text Key: 77627063
• Report Number: 3003639970-2017-00297
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151165
• 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: 07/06/2017

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: 11/21/2021
• Device Model Number: B0436534
• Device Catalogue Number: B0436534
• Device Lot Number: 616471V002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/26/2017
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 05/18/2017
• Supplement Dates FDA Received: 07/07/2017
• 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