MAUDE Adverse Event Report: MEDLINE INDUTRIES, INC. NEUROPACK; NEUROLOGICAL TRAY

Model Number DYNJ49357A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  Injury  

Event Description

During a cerebral angiogram.Catheter was placed within the appropriate portion of anatomy and physician attempted to do a hand contrast injection via the side port of the sheath.The syringe was connected and as he began to hand inject the 10 ml syringe broke at the plunger portion as well as the portion of the luer-lok, the tip within the luer-lok portion also broke off into our rotating hemostatic valve.No injuries luckily but we had to stop and use a different line - to continue with the case.The same exact scenario occurred on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: NEUROPACK
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUTRIES, INC.
• MDR Report Key: 8662454
• MDR Text Key: 146942633
• Report Number: MW5087080
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: DYNJ49357A
• Device Catalogue Number: DYNJ49357A
• Device Lot Number: 18KBV540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention