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

Catalog Number INS8401

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Medwatch uf/ importer report # (b)(4) was received on 20aug2021 with the following information: it was reported that the external ventricular drain (evd) tubing at the stopcock nearest to the patient was shattered.There was no known patient injury reported.Additional information has been requested.

Manufacturer Narrative

Accudrain with anti-reflux valve i(ns8401) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The reported lot number 546124 is missing one (1) digit; therefore, the documentation review was performed to 5416124 (ins8401).No anomaly was observed in the reviewed records that could be related to the reported condition.Given that the device has not been returned for evaluation, root cause determination is not possible at this moment.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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
• MDR Report Key: 12459793
• MDR Text Key: 271028963
• Report Number: 2648988-2021-00012
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: INS8401
• Device Lot Number: 546124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65