MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE; N/A

Catalog Number INS8400

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

Investigation completed (b)(6) 2018.The device was not to be returned for evaluation; customer did not keep the device.The lot number for the event was not identified.A list of 22 possible lots was provided and no related quality events and/or non-conformances (ncs) were recorded for any of the lot numbers; therefore, it is concluded that each lot complied with all in-process inspections and testing requirements as specified in the manufacturing shop order and related procedures.This complaint is unconfirmed.As an internal control, all units are leak tested during the manufacturing process.The customer provided additional information in which it was stated that: ¿a large needle was used through the csf patient port to administer a chemotherapy drug.This is their protocol in emergency situations.¿ the ifu makes the following statements: ¿the smartsite needleless site can be accessed with any standard luer fitting syringe.¿ ¿do not insert a needle into the needleless sampling site.¿ thus, it is concluded that the root cause of this event is user related due to hospital protocol in which a large needle is used through the needleless port in emergency situations.

Event Description

The customer reported that on an unknown date, the ins8400 accudrain patient port leaked when administering an emergency oncology drug.This resulted in removal of the drain.Additional information received on (b)(6) 2018 that a large needle was used through the cerebrospinal (csf) patient port to administer a chemotherapy drug.There was no adverse report to the patient from the product.In the facility's opinion, this was not a product failure.The accudrain was going to be removed anyway.This is their protocol in emergency situations.

• Brand Name: ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7353392
• MDR Text Key: 102945374
• Report Number: 2648988-2018-00008
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS8400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other