MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL; APPARATUS, AUTOTRANSFUSION

Model Number 8888571299

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/21/2017.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the tip of the connecting tubing was found detached from the tubing when opened.

Manufacturer Narrative

One (1) opened sample was returned to the site in relation to this complaint.A visual inspected was completed on the returned sample with no defect / no damage with the any tubing on the returned sample; the tube is in the correct position and there is no kink in the tube.During the visual inspection, it was observed that the suction port was damaged.It is unknown if this damaged occurred during the return process of the sample or if the customer experienced this damage as well.There were photos from the decontamination process which show the suction port broken.During the manufacturing of all aqua seal units they are all 100% leak tested and 100% functionally tested as part of the process.Also independent sampling is complete to confirm units are functioning correctly.A probable root cause for the damage to the suction port is that the damage occurred during the transport.A review of the complaint tracking system for previous complaints against the lot number found no previous complaints against this lot number.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 lot 16l142fhx.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AQUA-SEAL
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7138001
• MDR Text Key: 95601763
• Report Number: 9611018-2017-05014
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060965
• UDI-Public: 20884521060965
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2021
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 16L142FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1