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

Catalog Number INS8400

Device Problems Detachment Of Device Component (1104); Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

The stopcock failed.It popped out of the housing and was leaking cerebrospinal fluid (csf).Request for additional information has been sent.

Manufacturer Narrative

Additional information/clarification received from the customer on (b)(4) 2017: the nurse had to travel off of the floor for a test or procedure.She clamped the drain at both stopcocks.When she returned from the procedure, she tried to get an icp reading but was unable to.In trouble shooting the line, she found that the stopcock by the buretrol had popped out of the housing.The patient was still clamped but the csf in the line leaked out of the housing.There was no patient harm.Because the drain was in use, they discarded all the packaging; hence the lot number is not available.The customer did not have any of the patient demographics.

Manufacturer Narrative

Investigation completed 10/26/2017.Device history record (dhr) of lot number 1165306 was reviewed.The manufacturing and final pack processes ran normally; no anomalies were found during manufacturing process of the product.This lot was released to the market on december 07, 2016.A two year look back from july 2015 to july 2017 showed no manufacturing trends.One accudrain sample was received.It was observed that the patient line¿s stopcock was broken.Only the half of the stopcock¿s body was included; the other half and white plug were missing.It was also noticed that there was a crack on the stopcock¿s female port.The unit set had a transducer attached to the patient line, and the transducer itself had an additional stopcock (non- integra product) attached to it.This stopcock was also cracked.The most probable cause for this event is related to product handling during use.The breakage could have been caused by an unintended blow/hit, excessive force or any other fortuitous event during product handling outside of integra¿s control.The customer did not report any leaks in the system and none was observed during the verification of the returned samples.Therefore, it seems that the system behaved as it normally does, but not as the customer expected.This most likely explains why only the ins-8400 units (lot 1170009) seemed to cause the situation.

• 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: 6741198
• MDR Text Key: 80952206
• Report Number: 2648988-2017-00026
• 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,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS8400
• Device Lot Number: 1165306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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