MAUDE Adverse Event Report: COVIDIEN ARGYLE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 8888505040

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/27/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer reports yankauers were torn and dirty inside the pack.

Manufacturer Narrative

There were no samples submitted with this complaint.The complaint shall be reopened if a sample is received.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The reported condition could not be confirmed due to the lack of a returned sample from the customer therefore a root cause cannot be identified.The manufacturing process was reviewed and found that product was manufactured in accordance whit the specifications required under official product specifications.No corrective actions are deemed necessary at this moment due to the reported condition could not be confirmed.We will continue monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6527020
• MDR Text Key: 73913141
• Report Number: 9612030-2017-05062
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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: Other
• Device Model Number: 8888505040
• Device Catalogue Number: 8888505040
• Device Lot Number: 628519464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 03/31/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1