MAUDE Adverse Event Report: CENTURION; CIRCUMCISION TRAY

Catalog Number CIT6860A

Device Problem Dull, Blunt (2407)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

According to the customer on 1/9/2024, "the nicu team reported the scissors were dull and resulted in increased bleeding".The customer reported that this "prolonged the time of procedure" but that there was no medical treatment or follow-up required and that the "patient was discharged that afternoon".Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer on 1/9/2024, "the nicu team reported the scissors were dull and resulted in increased bleeding".

• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CENTURION; 4301 w markham st; little rock AZ 72205 7199
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18681845
• MDR Text Key: 335073568
• Report Number: 2032758-2024-00001
• Device Sequence Number: 1
• Product Code: OHG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CIT6860A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other