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

Catalog Number	821731C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cerebrospinal Fluid Leakage (1772); Fever (1858)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported an eds drainage system (id 821731c) was placed to treat persistent hydrocephalus post subarachnoid hemorrhage due to ruptured aneurysm.Eight days after placement csf leakage was noted at the tap which the "pressure head" was connected.The patient had staphylococcal ventriculitis with neurological deterioration 3 days after discovering the crack, treated with antibiotic therapy adapted to staph epi (vancomycin) started on (b)(6) 2023, relayed by linezolid: treatment for 14 days and change of evd system on (b)(6) 2023.Negative csf sample since (b)(6) 2023, and apyrexia on (b)(6) 2023.Neurological consequences for the patient: patient was in the awakening phase when ventriculitis occurred.The patient had loss/absence of response to simple orders/requests and spontaneous opening of the eyes.Outcome of the patient: the patient is doing better, she awakes progressively.She is still in icu and intubated.
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.
Additional Manufacturer Narrative
(b)(4).The eds drainage system was returned for evaluation: failure analysis - the eds was visually inspected: cracks and stress marks were noted in the patient line connector.The eds was set up per ifu.The eds was flushed leaked from the connector.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.Complaint confirmed.Root cause - the root cause for the for the cracks and stress marks found in the connector are due to over tightening when connecting devices, as noted in the ifu finger tighten only.The root cause for the leakage reported by the customer is due to the cracked connector.A possible root cause for the infection could be due to the patient and or the hospital surroundings, as no lot number was provided by the customer sterilization certificate could not be inspected.

• 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: 16856734
• Report Number: 3013886523-2023-00129
• Device Sequence Number: 20976535
• Product Code: JXG
• UDI-Device Identifier: 10886704079873
• UDI-Public: 10886704079873
• 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): 07/27/2023

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 Catalogue Number: 821731C
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown