MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SPECIAL EVD 10-110 W/O Y SITE; N/A

Catalog Number SP0090

Device Problems Detachment Of Device Component (1104); Product Quality Problem (1506); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

This is the first of five reports (same product, same product problem, same facility).The monitor drain transducer was disconnecting from the drain.No other information was provided.Additional information has been requested.Linked to mfr report: 2648988-2016-00052, 2648988-2016-00055, 2648988-2016-00053, 2648988-2016-00054.

Manufacturer Narrative

Integra has completed their internal investigation on 12/06/2016.The product was not returned for evaluation and no sample or photo has been received for this complaint at the time of this investigation; thus, could not be confirmed.Dhr review was not possible as no lot number was provided.Upon review of integra's complaint system from november 2014 to november 2016, there are eight (8) complaints (including these ones) related to ¿transducer disconnection¿ for the for external drainage (monitor) product family.At the moment all of the complaints are from the same facility.A device and a transducer were returned for complaint #(b)(4) and the complaint could not be duplicated, thus it was not confirmed.Monitor's connecting stopcock was in good state, no defect was detected.No other device has been returned for evaluation.So far no defects have been detected on the monitor evd device that could cause the disconnection events.The situation may be related to the transducer used or user related.The client hasn¿t disclosed information regarding the procedure used to attach the transducers (set-up), or if the events are isolated to certain users only.The client informed our clinical sales/ clinical education specialist that they are evaluating other transducers to use with product.Approximately (b)(4) units were released for distribution from november 2014 to november 2016.Therefore, the complaint occurrence rate for this type of incident is (b)(4).This was determined by dividing the number of complaints in this category (8) by the number of units released for distribution purposes (b)(4) times 100.Conclusion: no information was provided regarding the circumstances surrounding these events, only that the transducers disconnect from the drains.The transducer may be attached at any of two locations, as per ifu: ¿a pressure transducer may be attached proximate to the patient at the patient line stopcock or at the manifold stopcock for rigid mounting with the pole mounted bracket assembly.¿ the complaint does not inform for how long was it connected (prior disconnection), it doesn¿t say if the stopcock¿s was defective or broken, or if the transducer¿s connector was examined for defects.A possible cause may be that the luer lock was not properly tightened.User must ensure that the transducer (if from a different manufacturer) used is compatible with integra¿s device and that a secure connection is possible.No defects have been detected on the monitor evd product that could cause the disconnection events.The situation may be related to the transducer used or user related.The client hasn¿t disclosed information regarding the procedure used to attach the transducers (set-up), or if the events are isolated to certain users only.The client informed our clinical sales/ clinical education specialist that they are evaluating other transducers to use with product.Lot and catalog numbers for the device involved in this event are unknown.No device has been returned for evaluation and it is uncertain if the device will be returned.Further investigation is not possible.

Manufacturer Narrative

Medwatch uf/importer# (b)(4) received from fda on 19apr2017 with the following: event date: (b)(6) 2017.Patient transported to ct scan.While bathing patient shortly after return from ct, nurse noticed that ventriculostomy transducer was disconnected from ventriculostomy drain, and csf was dripping on to floor.Transducer cable had been taped to the ventriculostomy stand to ease tension on the connection.No known impact or consequence to patient.

Manufacturer Narrative

Integra has completed their internal investigation on may 10, 2017: results: evaluation of returned device; monitor unit was received with a transducer of an unknown manufacturer.The unit was visually inspected and was found to be in good condition.The manifold stopcock was verified and photographed: all were found in perfect condition.No defects were detected during the product inspection.The monitor stopcock has no moving parts.Stopcocks used are standard off the shelf products.The stopcock¿s luer threads were verified and no defect was detected.The complaint is considered not confirmed since the condition where the transducer would fall off without external intervention could not be reproduced and the only way evidenced for the two components to separate would be as the result of continuous or repetitive handling.Dhr review; the manufacturing and final pack processes ran normally; no anomalies were found during manufacturing process of the product.After verifying that the lot met all established requirements, this lot was released on july 21, 2016.The stopcock to which the transducer is connected was part number 2058-001 / lot 3160481.Release records were evaluated and no deviations were noted.The lot is released based on manufacturer certification of compliance.Nothing unusual was noticed in the dhr review that could have caused the reported event.Complaints history; upon review of integra's complaint system from november 2014 to november 2016, there are eight (8) complaints (including these ones) related to ¿transducer disconnection¿ for the for external drainage (monitor) product family.(b)(4).Conclusion: the condition where the transducer would fall off without external intervention could not be reproduced no defect was found on the stopcock of the monitor.No evidence was found that the device is the cause of the reported event the root cause is considered undetermined (although it could be related to the transducer or handling).

• Brand Name: SPECIAL EVD 10-110 W/O Y SITE
• 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: 6122855
• MDR Text Key: 60935376
• Report Number: 2648988-2016-00051
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K920156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP0090
• Device Lot Number: 1162632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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