MAUDE Adverse Event Report: COVIDIEN 2.5FR URETHANE UMB CATH; CATHETER

Model Number 8888160325

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/13/2016.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 a catheter.The customer reports that the numerical depth markings are missing.

Manufacturer Narrative

Submit date: 11/03/2016 a device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.Manufacturing quality (mq) performed functional, visual and dimensional evaluation with zero issues found.The product sample was returned for evaluation.It consisted of an umbilical vessel catheter (uvc) which came inside a plastic bag with its corresponding pouch of the product.The catheter showed signs of use (remains of an unknown substance inside the catheter).Visual inspection was performed and it was observed that the catheter did not have the numerical depth marks on it.A brainstorming session was performed with the purpose of identifying additional potential causes.Based on a fishbone diagram, the following potential causes were identified: the operator failed to follow procedures.The pieces are placed manually on the pad printer plate and printed one by one.100% of the devices have to be inspected visually to verify that the print is complete and legible.An additional visual inspection is also performed.Inspection not performed: an improper application of the in-process inspection is considered to be a contributing factor of this event.Unclear procedures, equipment, material, and environment had no potential causes identified.The reported condition has been confirmed.Based on all gathered information, it is considered that an incorrect operation in the pad printer stage added to an improper application of the in-process inspection.This is considered to be the most probable cause of this event.Therefore, the most probable root cause can be considered as manufacturing related.A corrective and preventative action (capa) was opened for this issue.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual and functional inspection and visual and functional acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual inspection during production, which would identify depth marks printing issues.This complaint will be used for tracking and trending purposes.

• Brand Name: 2.5FR URETHANE UMB CATH
• Type of Device: CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5720262
• MDR Text Key: 48168507
• Report Number: 1317749-2016-00001
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8888160325
• Device Catalogue Number: 8888160325
• Device Lot Number: 1508500090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1