MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML; N/A

Model Number INS9020

Device Problem Disconnection (1171)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

The limitorr volume limiting evd 20ml (ins9020)  was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.Three (3) photos were provided; however, the defect cannot be observed in any of them because the tubing/ stopcock junction was covered with adhesive tape and none showed the separated components.As per medwatch report, the device was implanted on (b)(6) 2022 and the reported disconnection occurred on (b)(6) 2022 when the neurosurgery provider was getting ready to obtain a csf sample.Thus, the device was in service for two (2) days prior the reported disconnection.It was also reported that the device was not immediately changed; instead, the ¿tube was reconnected secured with sutures, tape and tegaderm¿, and left in place until end of treatment on (b)(6) 2022.As per product ifu: any failure of the system requires immediate replacement of the drainage system.If the infection is related to this event, it is most likely due to not changing the broken device since the sterile barrier can only be assured if the device is undamaged; in this case, the use of a broken device was allowed for two (2) days.These components (clear tubing, green-stripe tubing, and stopcock) are bonded using a 50/50 mixture of cyclohexanone and methylene chloride.Both referred solvents were used within their respective expiration dates.Also, there is assurance that adhesive was applied during the assembly process because the tubing assembly is not possible unless the adhesive mixture is applied.This is so because, while wet, the adhesive serves as a lubricant so that the clear tubing slides into the stopcock fitting and likewise for the green-stripe tubing to slide into the clear tubing.Otherwise, is not possible to fit the components together; therefore, application of adhesive must have occurred to complete the assembly process.All limitorr units are tested for leaks which covers the reported disconnecting site: no failures/rejects were reported.In addition, no other complaint has been reported for lot 6566358.Possible root causes for a disconnection could be associated to product handling (e.G., inadvertently pulling the line, excessive bending of the patient line tubing next to the stopcock) or poor workmanship (although not supported based on available documentation and process review).An awareness training was provided to all personnel related to the tube to stopcock bonding operations.Awareness training ensures that personnel have knowledge of the reported event, event consequences, and to review bonding instructions per current procedure.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.

Event Description

A facility initially reported that the limitorr volume limiting evd 20ml (ins9020) was disconnected from stopcock in most distal part of tubing.The tubing de-glued or somehow came off the stopcock construct.They only used chloraprep to clean, 2% chg and 70% isopropyl alcohol.The tube wa reconnected secured with sutures, tape, and tegaderm.No patient injury or surgical delay was reported additional information received from customer via unnumbered medwatch on (b)(6) 2022: "patient s/p rathke's cleft cyst resection and fenestration.Integre limitorr 20 ml csf drainage collection system attached to lumbar drain came apart at a manufacturer - flued connection.Collection system placed on (b)(6) 2022.When reported to the integra rep they reported one previous event nationally of the same site coming apart due to acetone being used which dissolved the glue.The only chemical used on this drain was chlorhexidine.Patient developed csf infection which contributed to return to the operating room.".

• Brand Name: LIMITORR VOLUME LIMITING EVD 20 ML
• 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: 16040350
• MDR Text Key: 306066718
• Report Number: 2648988-2022-00030
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K072929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INS9020
• Device Catalogue Number: INS9020
• Device Lot Number: 6566358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Date Device Manufactured: 09/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female