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

Model Number 8888571299

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the product was broken at the bottom part that filters the liquid.Additional information provided on (b)(6) 2019 states that the issue occurred during use and caused the device to leak.

Manufacturer Narrative

Additional information was added to the investigation and device evaluation.See below: the device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of 18f133fhx.Three samples were returned for evaluation.Visual inspection was completed on all three vessels and the site can confirm the defect, the suction port valve is broken on two samples and the bottom of the vessel is broken on the third vessel.Due to further information received from the customer, they receive the product in a box with 5 units.As a result, it is confirmed that the units were not broken down in the case.During the manufacturing process all aqua seal vessels are 100% leak tested and 100% functionally tested.In order to complete the testing the vessel requires the suction port valve to be present and the vessel must be in the upright position.The bottom of the vessel needs to be intact.Also, independent sampling is complete by to confirm units are functioning correctly prior to release.A probable root cause for the defect is that damage occurred to the vessels during the transport / post testing.A corrective action is not applicable at this time.This complaint will be used for qa tracking and trending purposes.

Manufacturer Narrative

The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of 18f133fhx.Three samples were returned for evaluation.Visual inspection was completed on all three vessels and the site can confirm the defect, the suction port valve is broken on two samples and the bottom of the vessel is broken on the third vessel.The site has received information that the product in question is being shipped in quantities of one (1).Ship/shake transit testing for this product has been approved based on a quantity of 5 units per carton as is presented from the manufacturing site.Product damage will occur if this product is broken down into pieces.Therefore the probable root cause of the reported condition is that the product was damaged during transit.A corrective action is not applicable at this time.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer reported that the product was broken at the bottom part that filters the liquid.Additional information provided on 19-aug-2019 states that the issue occurred during use and caused the device to leak.Additional information provided on 20-aug-2019 stated that the syringes do not make a good seal, which does not allow for proper aspiration.

• Brand Name: AQUA-SEAL CDU
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 8913350
• MDR Text Key: 155050765
• Report Number: 9611018-2019-00315
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 18F133FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1