MAUDE Adverse Event Report: COVIDIEN ARG DLEE MUC TP W/FLT 20CC 10 FR STRL; OPEN SUCTION CATHETER

Model Number 8888257469

Device Problems Suction Problem (2170); Compatibility Problem (2960)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an open suction catheter.The customer states that the product is labeled as a 10fr catheter; however, when opened and compared to other delees it appears smaller than a 10fr.

Manufacturer Narrative

Submit date: 08/25/2016.One sample received had lot# 152680292x.A device history record (dhr) of the sample lot# was performed and confirmed that the product was produced accomplishing all quality requirements and was released according to all established procedures.One sample was received for evaluation.The received sample was evaluated visually and functionally and verified the condition reported.An 8 fr catheter was assembled instead of a 10 fr catheter.After investigation, the possible root cause was concluded as a supplier (possibly supplied incorrect catheter) or manufacturing issue (possible product mix during process).The supplier bought catheter was removed from ship to stock status from the manufacturing incoming inspection department.First article inspection was placed on the manufacturing floor and a qa alert was posted in the incoming inspection department as well as the manufacturing floor.The dhr investigation of lots before and after has shown no similar conditions at this time.A corrective and preventative action (capa) was opened at the manufacturing site to address this event.This complaint will be used for tracking and trending purposes.

• Brand Name: ARG DLEE MUC TP W/FLT 20CC 10 FR STRL
• Type of Device: OPEN SUCTION CATHETER
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes; libriamento a la p, la mesa; tijauna ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5787087
• MDR Text Key: 50100879
• Report Number: 1282497-2016-00478
• Device Sequence Number: 1
• Product Code: BYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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 Model Number: 8888257469
• Device Catalogue Number: 8888257469
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1