MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS 3 DRAINAGE SYSTEM; EDS 3 DRAINS

Catalog Number	821730
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Eds 3 drainage (id 821730) was not returned for evaluation as the product is not available for return; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.A photo was provided by the customer but it only shows the label of the device, product code, lot number, etc.The root cause(s) of the reported issue could not be determined.However, a possible root cause for the reported complaint is due to an error of eds set up.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 or Problem Description
A physician reported the burette of the external drainage system (id 821730) did not drain into the collection bag when the drip chamber stopcock was in a drainage position.The doctor has to drain the burette with a syrnge which exposes a contamination.The only way it drains was when the drip chamber stopcock was in drainage position and the patient line stopcock was in drainage position too, that generates a flow from the ventricles of the patient to the collection bag (another exposure to contamination).It was necessary to re operate the patient and replace the drainage system.The patient is a chilean female close to 30 years.

• Brand Name: EDS 3 DRAINAGE SYSTEM
• Common Device Name: EDS 3 DRAINS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18231815
• Report Number: 3013886523-2023-00417
• Device Sequence Number: 16950161
• Product Code: JXG
• UDI-Device Identifier: 10381780515586
• UDI-Public: (01)10381780515586(17)251130(10)6874023
• Combination Product (Y/N): N
• PMA/510(K) Number: K061568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 821730
• Device Lot Number: 6874023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female