MAUDE Adverse Event Report: HU-FRIEDY MFG. CO.,LLC HU-FRIEDY SWIVEL DIRECT FLOW; AF SWIVEL DIRECT FLOW RIGHT 30K

Model Number UI30SDR

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2014

Event Type  Injury  

Event Description

A student was using a swivel direct flow (after-five right or left) insert on a patient when the tip broke and was swallowed.Patient was hospitalized from (b)(6) and kept under observation to make sure the tip passes.They were discharged and asked to return for a follow-up x-ray.The patient did not return for the follow-up and has reported he is doing fine.

Manufacturer Narrative

The device has not been returned to hu-friedy for evaluation.No further information is available.Patient identifier and date of birth of patient is not known.The device does not have an expiration date, serial number, or udi number.The device is not an implantable device.(a) nda# does not apply.Ind# - does not apply.Bla# does not apply.Does not apply.Does not apply.

• Brand Name: HU-FRIEDY SWIVEL DIRECT FLOW
• Type of Device: AF SWIVEL DIRECT FLOW RIGHT 30K
• Manufacturer (Section D): HU-FRIEDY MFG. CO.,LLC; 3232 north rockwell st.; chicago IL
• Manufacturer Contact: maria vrabie, director of ra ; 3232 north rockwell st.; chicago, IL 60618 ; 7738685676
• MDR Report Key: 4360448
• MDR Text Key: 5112868
• Report Number: 1416605-2014-00009
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UI30SDR
• Device Catalogue Number: UI30SDR
• Device Lot Number: 0610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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
• Treatment: NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES; REPORTED.
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 73