MAUDE Adverse Event Report: COVIDIEN BLUNTIP NDL I.V. ACCESS; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881540101

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the radiology department receives prefilled syringes from the nuclear medicine department.When the radiology team tries to inject through the "rubber hub" (iv access blunt tip), it comes loose and substance comes out of the syringe causing radio contamination.

• Brand Name: BLUNTIP NDL I.V. ACCESS
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10248090
• MDR Text Key: 198120549
• Report Number: 1017768-2020-00831
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521082915
• UDI-Public: 10884521082915
• 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
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881540101
• Device Catalogue Number: 8881540101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1