MAUDE Adverse Event Report: CAREFUSION, INC GENESIS RETENTION PLATE; RETENTION PLATE, TOP STANDARD CONTAINER

Catalog Number RP40-1

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The sample was discarded by user.Therefore, a thorough investigation could not be determined for the reported failure.Since an investigation could not be performed a definitive root cause could not be determined for this event.A review of the device history record could not be performed as the reported lot was unknown.If any additional information is provided a supplemental emdr will be submitted.No device was available for evaluation.

Event Description

It was reported that the retention plate for a rp40-1 container broke and had a sharp edge causing a cut to the user.The retention plate was discarded and is not available as a sample.No additional information was provided about the injury to the user.

• Brand Name: GENESIS RETENTION PLATE
• Type of Device: RETENTION PLATE, TOP STANDARD CONTAINER
• Manufacturer (Section D): CAREFUSION, INC; 17820 englewood dr; cleveland OH 44130
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 17820 englewood dr; cleveland, OH 44130 ; 8015652341
• MDR Report Key: 10490571
• MDR Text Key: 205579684
• Report Number: 1423507-2020-00033
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RP40-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other