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

Model Number 8888571299

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the device's corrugated tubing sleeve was detached prior to use.There was no patient involvement.

Manufacturer Narrative

An investigation of the reported condition was performed.The complaint report indicates that no sample was available for evaluation.Without a sample, we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately, without a sample we are unable to confirm the reported condition.If a sample should be returned at a later date this complaint will be re-opened and the investigation will be updated to reflect our findings.During manufacturing of this product, each unit was functionally tested to ensure it functions properly.Also, independent qa sampling was completed to ensure there are no issues.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot.Based on the complaint description the most probable root cause may be that the tube was not assembled correctly or dislodged post production.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: 6924421
• MDR Text Key: 89241615
• Report Number: 9611018-2017-05010
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 16I164FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1