MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. SET ADMINISTRATION INTRAVASCULAR CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Event Description

Information received a smiths medical cadd accessories cassette medi reservoir bag ripped inside the cassette, while mixing 80 milliliters volume.The patient complained of headache because the contents of the medication remoldulin spilled onto his abdomen and feet.No further adverse patient events reported.No lot number available ,nor was device returned.Caregiver reported incident.

• Brand Name: SET ADMINISTRATION INTRAVASCULAR CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9179154
• MDR Text Key: 169085881
• Report Number: 3012307300-2019-05567
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5089364
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 90