MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH ANTI-REFLUX VALVE; N/A

Catalog Number INS8401

Device Problem Crack (1135)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that on (b)(6) 2020, the stopcock of the ins8401 accudrain with anti-reflux valve broke apart and leakage was noted on the bed next to a (b)(6) female patient's head.They were unable to estimate the amount of leakage.A new external ventricular drain (evd) was set up and connected to the patient.Cerebrospinal fluid (csf) cultures were taken.

Manufacturer Narrative

One used accudrain unit was received and the device was visually inspected.It was noticed that the lot number of the device (4079779) was different to the one reported in the complaint (4145815).Also, a metal plate with the number 198 engraved on it was attached to the device by means of a rubber band.The stopcock was inspected and, as previously observed in the photos provided by the customer, the stopcock was split in two (2) parts and a cloudy/opaque area was observed on its surface.The cloudy/opaque appearance indicates that the stopcock may have come in contact with an unknown chemical substance which triggered its breakage.Based on an engineering study and supplier information, it has been demonstrated that when the stopcock comes in contact with collodion remover or acetone, the stopcock appearance turns opaque and the stopcock cracks.No anomalies were detected during documentation review that could have caused the reported condition.The broken stopcock condition was considered confirmed.From the information provided by the customer.It was not possible to determine if the stopcock was exposed to the mentioned conditions that could trigger the breakage.Nonetheless, the stopcock appearance (cloudy/opaque) suggests that the stopcock came in contact with an unknown chemical substance triggering its breakage.Therefore, the most probable root cause was related to unknown chemical exposure.Description: reported lot / received unit lot: lot number: 4145815 / 4079779, catalog number: ins-8401 / ins-8401, device identifier: (b)(4).Product identifier: (b)(4).Manufacturing date: november 02, 2019 / september 24, 2019.Expiration date: october 31, 2021 / august 31, 2021.

• Brand Name: ACCUDRAIN WITH ANTI-REFLUX VALVE
• 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: 10280711
• MDR Text Key: 202935956
• Report Number: 2648988-2020-00015
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: INS8401
• Device Lot Number: 4079779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR