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 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states during pre operation, the device's corrugated tubing sleeve was detached.

Manufacturer Narrative

Submission date: 08/31/2018.An investigation was performed for the reported customer complaint: ¿the customer states during pre operation, the device's corrugated tubing sleeve was detached.¿ a review of the device history records (dhr) for reported lot number 16i164fhx indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.There were no manufacturing issues related to the complaint for this lot.An additional sample was provided for evaluation.One (1) opened sample was received.Visual inspection noted no damage with the corrugated tubing.The tube is in the correct position and no bend was evident.It was observed that the suction port has damage.It is unknown if this damage occurred in the return process of the sample or if the customer experienced this damage as well.A probable root cause for the damage to the suction port is that the damage occurred during the transport.The reported customer complaint of corrugated tubing sleeve was detached is not confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within a cceptable limits during the production process of lot 16i164fhx.A sample was received at the manufacturing site and an investigation into the reported condition was performed.One (1) opened sample was returned to the site in relation to this complaint.A visual inspected was completed on the returned sample; there is no damage with the corrugated tubing on the returned sample, the tube is in the correct position and there is no kink in the.As observed during the visual inspection the suction port was damaged.The site has reached out to clarify where this damage took place and if the customer experienced this damage.It is unknown if this damaged occurred on the return process of the sample or if the customer experienced this damage as well.A probable root cause for the damage to the suction port is that the damage occurred during the transport.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: 6991962
• MDR Text Key: 91210583
• Report Number: 9611018-2017-05012
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060965
• UDI-Public: 20884521060965
• 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,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• 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
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: Initial
• Patient Sequence Number: 1