MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Break (1069)

Patient Problems Sepsis (2067); Septic Shock (2068); Cardiogenic Shock (2262); Drug Resistant Bacterial Infection (4553)

Event Date 07/03/2021

Event Type  Death  

Manufacturer Narrative

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 reported that the patients umbilical venous catheter (uvc) was found broken.Additional information was received and stated that the catheter was inserted on (b)(6) 2021 in nicu operating room.Prior to insertion the skin area was cleaned with betadine.The area was completely dried prior to insertion.The prevantics (pdi) device swab (contains 70% (v/v) isopropyl alcohol) are only used to clean the needless cap that is attached to the terminal port of the catheter distal to the patient end.The pdi swabs were not used to clean the body of the catheter.There was no difficulty in handling the catheter during insertion.The catheter was secured with suture and bridge without any difficulty.The catheter was used continuously and 10 ml syringe with normal saline was used to flush the line.On (b)(6) 2021, the patients uvc was found to be broken just below the molded strain relief on the extension.There was no fragment of the catheter retained inside the patient.The catheter was removed and replaced with double lumen 3.5 fr.Umbilical catheter.The patient showed signs and symptoms of infection and decompensated.The patient died later that same day due to (b)(6) sepsis with cardiogenic/septic shock.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12413731
• MDR Text Key: 269528149
• Report Number: 3009211636-2021-00761
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• 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
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death