MAUDE Adverse Event Report: COVIDIEN 1.9F ARGYLE SINGLE LUMEN PICC; CATHETER, UMBILICAL ARTERY

Model Number 43303

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but at this time has not yet been received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports that upon assessment of picc line dressing, dressing appears soiled; leaking from under the dressing present.Sterile dressing change performed.Leaking visible from picc catheter while exposed during sterile dressing change.Line removed and a peripheral intravenous (piv) line was placed.

Manufacturer Narrative

One sample was returned to the plant for the investigation.The sample arrived in a generic plastic bag and the catheter showed signs of use (residues of blood).Because a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A visual inspection and under-water test were performed on the sample, and the reported condition was confirmed.A leak below the strain relief was observed in the catheter.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed at the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.100% leak test are performed therefor a leakage crack would be deterred during these processes.Based on the available information, it can be concluded that the product was manufactured according to specifications, therefore the most probable root cause can be considered as user misuse.This defect is likely a result of the product being damaged during use due to inappropriate manipulation.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 1.9F ARGYLE SINGLE LUMEN PICC
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8375532
• MDR Text Key: 137376615
• Report Number: 3009211636-2019-00644
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1