MAUDE Adverse Event Report: ANCILLARY SUPPLY; SYRINGES

Device Problems Air Leak (1008); Detachment Of Device Component (1104); Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 12/22/2014

Event Type  Other  

Event Description

Patient's wife reported that her husband's last order or syringes for mtx seem to be defective.Patient has had issues with air bubbles reviewed in technique to avoid this and she also said 1 needle became detached from syringe after patient injected med and needle stayed in arm.She feels as if these needles are dull as well.

• Brand Name: ANCILLARY SUPPLY
• Type of Device: SYRINGES
• MDR Report Key: 4531301
• MDR Text Key: 15111231
• Report Number: MW5040784
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR