MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 5/0 (1) 45CM DS16; OTHER SUTURE

Model Number G0712124

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation ongoing.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that the box containing suture packages was received incorrectly labeled.Prior to use, it was noted that there had been a mix-up with the printing on a box.The customer had ordered supramid sutures and the box had monosyn labeling.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Aesculap inc.(importer, registration no.(b)(4)) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer, registration no.(b)(4)).Exemption number: e2014012.Pma/510k: k990090.Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.

• Brand Name: SUPRAMID BLACK 5/0 (1) 45CM DS16
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8259079
• MDR Text Key: 134196821
• Report Number: 3003639970-2019-00054
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: G0712124
• Device Catalogue Number: G0712124
• Device Lot Number: 618386
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/14/2019
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1