MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH AN EXTRA FOOT OF PATIENT LINE AND; N/A

Catalog Number SP0213

Device Problem Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

Accudrain was not returned for evaluation (the drain was not kept to send it in for evaluation) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Linked to mfg report number: 2648988-2020-00038; 2648988-2020-00040.

Event Description

This is 2 of 3 of reports - same product, different patients.A facility reported the accudrain was leaking around the transducer stopcock.There was no known medical intervention done.Additional information has been requested.

• Brand Name: ACCUDRAIN WITH AN EXTRA FOOT OF PATIENT LINE AND
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10820213
• MDR Text Key: 216682820
• Report Number: 2648988-2020-00039
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP0213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1