MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE; MAV SYRINGE, BALLOON INFLATION

Catalog Number CID-20-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, the 3-way stop cock does not tighten and "pops" off of the sphere inflation device.The device did not make patient contact.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device will not be returned to the manufacturer for investigation.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history records for the complaint lot indicated that the devices were manufactured under normal operating procedures.The device were sampled, inspected, and accepted per specification.There was one other reported complaint for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SPHERE INFLATION DEVICE
• Type of Device: MAV SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7678111
• MDR Text Key: 113889615
• Report Number: 1820334-2018-01710
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210228(10)96271388
• Combination Product (y/n): N
• PMA/PMN Number: K953522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1