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

Model Number 8881570121

Device Problems Backflow (1064); Device Slipped (1584); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7/9/2018 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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports: when priming our microclave, when they would let go of the plunger on our prefill syringes the fluid would drain back into the syringe.The plunger is slipping back whether or not the microclave is attached or not.Follow up information was received from the customer who stated the plunger is not sealed to the barrel of the syringe.

Manufacturer Narrative

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: 7669618
• MDR Text Key: 113746264
• Report Number: 2182208-2018-01255
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 06/12/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1