MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number 09-6551D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Event Description

Patient called provider's office to report they believed their nexplanon implant was broken.Provider examined the patient in office and the device did appear to be broken.After discussion with the patient, the patient wished to have the broken rod removed and replaced with a new one.Procedure was completed uneventfully.

• Brand Name: CARDINAL HEALTH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy; fort mill SC 29707
• MDR Report Key: 7530553
• MDR Text Key: 108806060
• Report Number: 7530553
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 09-6551D
• Device Catalogue Number: 09-6551D
• Device Lot Number: 164280
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2018
• Date Report to Manufacturer: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR