MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. RESERVOIR, CASSETTE, 100ML, FS 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7302-24

Device Problem Defective Device (2588)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the product was postponed due to the possibility of a cassette disconnection alarm.The event occurred upon opening the package/carton.There was no patient involvement and no patient harm.

Manufacturer Narrative

B3: event date unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

One sample was received in unused condition.Visual and functional testing found no discrepancies.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: RESERVOIR, CASSETTE, 100ML, FS 12/BX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19097374
• MDR Text Key: 340509013
• Report Number: 9617604-2024-00319
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: Health Professional
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4235238
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2024
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1