MAUDE Adverse Event Report: IV BAG, 500ML 3-LEG (WLF); CONTAINER, I.V.

Catalog Number TPNGR500ML

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

Transfer tubing "eva tpn bag w/ detachable 3 leg transfer set" was found to be broken near connector for attachment of pooling bag during pooling process and medication lost due to leakage.Fda safety report id# (b)(4).

• Brand Name: IV BAG, 500ML 3-LEG (WLF)
• Type of Device: CONTAINER, I.V.
• MDR Report Key: 15626600
• MDR Text Key: 302024988
• Report Number: MW5112705
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TPNGR500ML
• Device Lot Number: V2133318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 83 KG