MAUDE Adverse Event Report: DEPUY MITEK 4503 USA IRRIGATION TUBE SETS PK/24 -SH; FMS TUBING

Catalog Number 284504

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Extravasation (1842)

Event Date 10/21/2014

Event Type  Injury  

Event Description

The sales rep reported during an acl procedure, the pump was not reading the pressure, and continued working.It was noticed that the patient's thigh was slightly expanded.They replaced the tubing and completed the procedure.They kept an eye on the patient, and later same day was released.The sales rep stated he was not present, but believes the transducer cap was not secured properly and will provide in service review on how to set up the tubing.The tubing was discarded.

Manufacturer Narrative

The complaint tubing is not being returned and therefore is not available for a physical evaluation.It was noted that the transducer cap may not have been secured properly during procedure which possibly led to the reported failure.Other than this possibility, a root cause for the reported failure cannot be determined from the details provided.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Based on the low occurrence rate of this failure, at this point in time, no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 4503 USA IRRIGATION TUBE SETS PK/24 -SH
• Type of Device: FMS TUBING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4244123
• MDR Text Key: 5015883
• Report Number: 1221934-2014-00498
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2014
• Date Manufacturer Received: 10/21/2014
• 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