MAUDE Adverse Event Report: COVIDIEN MONOJECT; SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570121

Device Problem Material Discolored (1170)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/22/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the prefill fluid in the syringes are cloudy and turning a yellowish color after being received.A patient reported a burning sensation and had to go to er.The results of the er concluded that there was no "burn" or injury to the patient.

Manufacturer Narrative

An investigation of the reported condition was completed.There were no samples received with this complaint therefore an examination of the reported condition could not be made.A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.This product was being used for treatment or diagnosis.A root cause analysis could not identify a root cause without a sample to evaluate.Since this complaint will be considered as unconfirmed, no corrective or preventive actions will be taken at this time.If additional information or samples are received, the investigation will resume as needed.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): COVIDIEN; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7289966
• MDR Text Key: 100729404
• Report Number: 2182208-2018-00312
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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