MAUDE Adverse Event Report: CODAN US CORP. CODAN TRIFURCATED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number BC 301-SUB

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hypoglycemia (1912)

Event Date 04/28/2021

Event Type  Injury  

Event Description

Pt's tpn filter was found to be leaking tpn fluids into pt's bed, there was a puncture in the filter.It was found by rn caring for patient during linen change.Pt's blood sugar was checked and it was 52, the tpn trifurcate with filter was replaced and pt's sugar was re-check before next care time and it was 93.Fda safety report id # (b)(4).

• Brand Name: CODAN TRIFURCATED EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORP.
• MDR Report Key: 11790010
• MDR Text Key: 249704229
• Report Number: MW5101227
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC 301-SUB
• Device Catalogue Number: REF97.6999
• Device Lot Number: 73174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 DA