MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that a premature baby on day of life (dol) one developed worsening discoloration of his abdomen and testes and abdominal distention on (b)(6) 2021.After evaluation by surgical services and an abdominal ultrasound, fluid was noted in the abdomen.There were no complications placing or securing the umbilical vessel catheter dual lumen (uvc) other than it being in a low lying position which was secured by tape bridge on (b)(6) 2021.Xray commented on abnormal path on the initial read, though it drew blood.A replacement of the uvc was attempted with a new device just after birth in the delivery room.That same day they attempted replacement again in the nicu with a new device because of unresponsiveness to pressors (5f dl).They were concerned that the pressors were not working.The uvc was found to be low lying again and was secured in the low lying position.A stat abdominal ultrasound was performed.There was concern for the uvc eroding through the vessel.Infusates were dopamine, blood, ffp, tpn/il.Concern was raised by the surgical team that the patient may have had an injury during the initial uvc placement and in the setting of coagulopathy caused injury and extravasation of fluid in the abdomen.Due to worsening ventilation status and increased girth in the setting of maximum medical management to correct coagulopathy and pressors, the decision was made with surgery, the nicu team, and the patient¿s parents to put in a surgical drain on dol two.Peritoneal fluid was sent for triglycerides (821) and glucose (1165).Total 95 ml/kg of bloody serous drainage was collected and weighed.The findings were consistent with tpn infusion intra-abdominally.The decision was made to pull the uvc which was removed on dol two as the line malpositioned and was infusing medications and fluids into the abdomen.The patient had improved coloration of their abdomen and less distention after the drain.The patient died at (b)(6) because of severe intracranial hemorrhage which was seemingly unrelated.Additional information provided by the reporter on june 09, 2021 stated that the baby was born via urgent c-section due to fetal distress and had head bleeds upon birth.The uvc did not malfunction.However, the team knew that what was being given to the baby was not going into their blood vessels.The customer does not know if there was any correlation between the passing of the baby and the uvc but the head bleeds did seem to be unrelated to the line.The cause of death is not available.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 12050289
• Report Number: 3009211636-2021-00755
• Device Sequence Number: 17246161
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 1916900048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 1 DA