MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG CONTIPLEX; NERVE BLOCK TRAY

Catalog Number 4898710-01

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).No sample has been returned for investigation.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.After checking the respective documentation of the production (shift protocol, results of self-control and in-process control of the workers, machine documentation, cleaning protocol, etc.), no deviations were found in the period mentioned.If the sample and or additional pertinent information becomes available, a follow up report will be submitted.Note: this report is being filed for an item number that is not sold in the united states; however, similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter tip left in a patient.

• Brand Name: CONTIPLEX
• Type of Device: NERVE BLOCK TRAY
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 10183622
• MDR Text Key: 197937465
• Report Number: 9610825-2020-00123
• Device Sequence Number: 1
• Product Code: OGJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4898710-01
• Device Lot Number: 19K17A8701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1