MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Leak/Splash (1354)

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

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/23/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states there is a pin point hole on the catheter that caused leaking of droplets of blood while the infant is being held by his mother.Minor loss of blood as a result.The catheter was removed from the infant.

Manufacturer Narrative

Submit date: 03/30/2017.Additional information regarding the product issue was received from the customer.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The cord and skin were cleaned with betadine and alcohol per protocol.The agents are allowed to dry for optimal antimicrobial effect.The customer did not hear that the insertion was difficult.There was no difficulty securing the product.It is loop sutured to the umbilical jelly, then secured to the skin with tegaderm atop extra thin duoderm.The catheter was inserted in the umbilical vein for continuous use on (b)(6) 2017 and removed (b)(6) 2017.Either 3 ml or 10 ml 0.9% nacl syringes were likely used to flush the line.Nothing is used to clean the device.It is inserted under sterile procedure.It is not cleaned after insertion.The device was replaced with a peripheral iv.The patient is progressing.Discharged to hospital closer to home.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6430125
• MDR Text Key: 70749591
• Report Number: 3009211636-2017-05047
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1