MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS DRAINAGE SYS NO V CATH; CSF DRAIN SYS/CRANIAL ACCESS

Model Number	82-1731C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported a eds drainage system was replaced due to broken screw resulting the system to fall.Csf leakage was observed at thread screw.
Additional Manufacturer Narrative
The eds drainage system was returned for evaluation: dhr - conformed to the specifications when released to stock failure analysis - eds was visually inspected, no defects were noted.The eds was set up per ifu.The eds was filled with di water, the drip chamber stop cock was opened, the water flowed into the collection bag no leakage was noted.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.No root cause could be determined as the technician could not confirm any leakage with the eds at the time of investigation.The possible root cause of the problem reported by the customer is probably due to users error it is possible that the collection bag was not correctly connect this causing a leakage and the bag to full off.

• Brand Name: EDS DRAINAGE SYS NO V CATH
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• 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: 13591186
• Report Number: 3013886523-2022-00060
• Device Sequence Number: 19798398
• Product Code: JXG
• UDI-Device Identifier: 10886704079873
• UDI-Public: (01)10886704079873(17)221231(10)4266367
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 82-1731C
• Device Catalogue Number: 821731C
• Device Lot Number: 42663667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• 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 Age: 59 YR
• Patient Sex: Unknown