MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH ANTI-REFLUX VALVE; N/A

Catalog Number INS8401

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Sus voluntary event report foi for manufacturers (mw5100029) was received with following information: "a male patient was admitted for endovascular repair of a 5.8cm descending thoracic aortic aneurysm.An integra lumbar spinal drain was inserted at the l4/l5 interspace to allow the removal of cerebrospinal fluid (csf) and the measurement of the lumbar csf pressure, and spinal cord perfusion pressure.We do this because the procedure carries a risk of spinal cord ischemia and paraplegia.The spinal drain was then connected to an integra accudrain external csf drainage system, and the anesthesiologist prepared the patient for the induction of general anesthesia.Propofol was injected through the administration port, and then they realized that the propofol had been injected through an identical port in the lumbar csf drain tubing, most of which refluxed back into the lumbar drain but several cubic centimeters (cc) were injected into the lumbar csf space via the drain.The injection was stopped, induction continued via properly identified intravenous tubing and port, and the lumbar csf drain was removed and replaced.The original unit was impounded for investigation.It is our contention that the integra accudrain is poorly designed and that the injection ports must be removed from the tubing as they represent a patient hazard.The case continued.A tevar with laser fenestration and stent for celiac and sma and chimney left renal artery stent was performed uneventfully.The patient was awakened, gross neurologic examination was intact and they wee watched overnight, 24 hours after surgery.The lumbar drain was removed with no neurologic sequelae and the patient is recovering in the hospital." information initially reported from the facility prior to receipt of the medwatch reported the following: propofol was injected in error.The injection port was mistaken for an iv injection port.Since there is no reflux valve part of the injectate with back in to tubing set and forward, reflux valve would of prevented all of the injectate; would have went into the correct location instead of patient.There was a 10 minute surgery delay with no adverse consequences to the patient.We were then further advised that 20cc csf was removed from catheter; drain kit was replaced with same model, injection port taped off.The product was retained and the icu/or staff was advised about the new drain kit and the identical injection port as the iv tubing.They advised that never had a spinal drain kit with an injection port, let alone one identical to iv tubing (minus the subtle yellow markings).Additional information received from facility after receipt of the medwatch indicates the following: there was no serious event likely to the quick recognition it was not the iv port.Removing the 20cc of csf with a syringe was an attempt to minimize the amount of propofol injected into the csf and remove any remaining in the catheter.It was cloudy, likely due to the propofol since it was clear when the catheter was initially placed.

Manufacturer Narrative

The device history record (dhr) was reviewed and no anomaly was observed in the dhr review of the reported lot number.As reported, the needleless y-site ports may get confused with other manufacturers device ports of the same type.Nonetheless, integra¿s evd products have safety features to prevent this type of reported event (1) bright yellow labels one (1) inch long with the words ¿csf access¿ (all capital letters) to help differentiate from other ports, (2) green stripe on patient line tubing.Integra is currently working on a preventative action to differentiate integra sampling ports from other devices in the market.

Event Description

N/a.

• Brand Name: ACCUDRAIN WITH 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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11723309
• MDR Text Key: 268445126
• Report Number: 2648988-2021-00006
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: INS8401
• Device Lot Number: 4566596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Date Device Manufactured: 06/08/2020
• 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