MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL CDU; BOTTLE, COLLECTION, VACUUM

Model Number 8888571299

Device Problem Suction Failure (4039)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

trending from 28^th jan 2019 to 28^{th t} jan 2020 inclusive was carried out for this code found 10 previous complaints have been received.

trending from 28^th jan 2019 to 28^th jan 2020 inclusive was carried out for this failure mode on this code and no previous complaints of a similar nature have been received

a review of the complaint tracking system for previous complaints against the lot number found no previous complaint.The associated data will be fed into the risk management quarterly report.

the dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of 17g235fhx

.

Event Description

The customer reported that the device did not work; it does not vacuum presumedly from the thorax tube connection.

Event Description

On hold.H10 section has no text, but text in image.Ck 5/22/2023.

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

• Brand Name: AQUA-SEAL CDU
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): IRL08 IRELAND-TULLAMORE; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048
• MDR Report Key: 9695898
• MDR Text Key: 199861537
• Report Number: 9611018-2020-00400
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 17G235FHX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1