MAUDE Adverse Event Report:; SALINE, VASCULAR ACCESS FLUSH

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, (b)(6) reported that the luer of the amusa 10ml in 12ml 0.9% sodium chloride flush syringe broke when removing the syringe from a catheter (reference 1000151124-2016-00011).(b)(4), amusa qa supervisor, contacted ms.(b)(6), rn, at (b)(6) , to gain more information regarding the alleged event.Ms.(b)(6) stated there was a previous incident involving a broken luer approximately 3 weeks prior to the event reported as 1000151124-2016-00011.No further information is documented for the previous alleged occurrence of a broken luer.

Event Description

The luer of a flush syringe allegedly broke when disconnecting from a catheter hub, staying lodged in the hub.

• Brand Name: UNK
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer Contact: dave meily ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 6183764
• MDR Text Key: 62695871
• Report Number: 1000151124-2016-00012
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1