MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS3 DRAINAGE SYSTEM; CSF DRAIN SYS/CRANIAL ACCESS

Model Number	82-1730C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
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 broken thread between collection bag and eds3 drainage system.The issue happened when changing the collection bag and the drainage system had to be replaced on (b)(6) 2022 which took 20 minutes and patient care was delayed 1 hour.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The eds3 drainage system was returned for evaluation: failure analysis - eds iii without collection bag was returned for investigation.Eds was visually inspected, the connector from the drip chamber to the collection bag was broken, stress marks were noted in the in the connector this is probably due to atypical force when connecting the collection bag.The eds was leak tested failed, leaked from the cracked connector.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.The root cause of the problem reported by the customer is probably due to users error by using atypical force when attaching the collection bag, as noted in the ifu ¿finger tighten only when attaching devices¿.
Event or Problem Description
N/a.

• Brand Name: EDS3 DRAINAGE SYSTEM
• 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: 14565870
• Report Number: 3013886523-2022-00230
• Device Sequence Number: 5083009
• Product Code: JXG
• UDI-Device Identifier: 10886704079866
• UDI-Public: 10886704079866
• Combination Product (Y/N): N
• PMA/510(K) Number: K172537
• 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): 07/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 82-1730C
• Device Catalogue Number: 821730C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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