MAUDE Adverse Event Report: COVIDIEN 1.9 FR ARGYLE DUAL LUMEN PICC; CATHETER, UMBILICAL ARTERY

Model Number 43304

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

Customer reports that the primary lumen was found to be cracked during flushing.The baby did not lose a significant amount of blood and required a peripheral iv to be started to keep the tpn running.Patient was stable.The baby received an unnecessary poke for the iv.

Manufacturer Narrative

A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.One sample was received at the plant for investigation.The sample consisted of one used picc catheter, which came inside a generic plastic bag.Additionally, the catheter showed signs of use (residues of blood).Both a visual inspection and under water test were completed and the reported condition was confirmed.A leak under the butterfly was identified in the catheter.Based on the investigation results and available information, it can be concluded that product was manufactured according to specifications, therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use caused by an 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.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 in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 1.9 FR ARGYLE DUAL LUMEN PICC
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8514914
• MDR Text Key: 142054782
• Report Number: 3009211636-2019-00655
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 1725600094
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1