MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOTOME MR BIOPSY KIT; BIOPSY INSTRUMENT

Model Number MUK303

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the customer which prevents a full investigation and analysis of the root cause.Customer follow-up attempts to provide addition information in regards to the sequence of events leading up to this complaint have been unsuccessful.Although we do not have the actual device for analysis, nor the lot number to assess the dhr for any anomalies during production, analysis of the assembly process determined that this defect would have been found if caused by the assembly process.During the assembly process, each probe is tested at the assembly plant 100% for leak, including the tubing fittings referred to within the complaint text.This event will be tracked and monitored for trends by the devicor complaints management staff.The tech that was affected by this event was sent to the emergency room for follow-up care and blood exposure testing.It was confirmed by the sales rep that all blood work from the tech came back negative.However due to the follow-up treatment and testing in the emergency room, we are submitting this medwatch pursuant to 21 cfr 803.Device discarded by customer.

Event Description

The sales rep reported that the muk303 tubing on the probe broke off and splattered blood all over the doctor and the tech.There was no patient consequence, however the tech did go to the er for blood exposure testing.

• Brand Name: MAMMOTOME MR BIOPSY KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 5762915
• MDR Text Key: 48589434
• Report Number: 3008492462-2016-00027
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MUK303
• Device Catalogue Number: MUK303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other