MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM; N/A

Catalog Number 10110

Device Problems Break (1069); Crack (1135)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 2648988-2019-00070, 2648988-2019-00071, 2648988-2019-00073, 2648988-2019-00013, 2648988-2019-00014, 2648988-2019-00015, 2648988-2019-00016, 2648988-2019-00017.

Event Description

This is 3 of 4 reports.A medwatch form with uf/ importer report # (b)(4) was received on 04jun2019 with the following information: there were several events related to the external ventricular drains (evds) leaking at the junction where the evd connects to the transducer set up.The evds were then clamped in two places: proximally nearest patient and distally at the distal stopcock to prevent exposure.The patients were immediately referred to the neuro surgery provider who changed the collection device on all of the patients.The patients did not have any adverse outcomes related to the device failures.Integra evd devices used were ins9030 limitorr volume limiting evd 30 ml (lot number 2919890) and 10110 csf drainage system with pole mount system (lot number 3242571).The customer did not specify which integra device was used on which patient.Additional information was received on 13jun2019 from the customer that all of the evds were cracked and leaking, requiring removal and replacement.One of the patients reported was a (b)(6) male patient with a diagnosis of intracranial hemorrhage.The date of the event occurred on (b)(6) 2019.

Manufacturer Narrative

The product was not returned.The device history record showed no anomalies were found to indicate product failure during manufacturing process of both finished good products.The reported complaint was not confirmed.An investigation for cause was unable to be performed.Nonetheless, the reported condition was consistent with previous complaints received.The most probable root cause has been identified to be related to the stopcock supplier.Udi number: (b)(4).

Event Description

N/a.

• Brand Name: CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
• 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 00610
• MDR Report Key: 8743608
• MDR Text Key: 149548309
• Report Number: 2648988-2019-00072
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K920156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 10110
• Device Lot Number: 3242571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS LIFESCIENCES TRANSDUCER; EDWARDS LIFESCIENCES TRANSDUCER
• Patient Age: 24 YR