MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/BX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7047-24

Device Problems Excess Flow or Over-Infusion (1311); Air/Gas in Device (4062)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that the pump was scheduled to finish however the pump never beeped.The pump was left to run longer but did not reach empty.Air was noted.83.30 ml was given but the cartridge was dry.No patient injury was reported.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: lot number, expiration date, and h4: manufacturer date are unknown.H3: device has not been returned to manufacturer.

Manufacturer Narrative

D9: date returned to mfg 3/4/2024 one sample was received for evaluation.Visual inspection revealed no damage or other defects.Functional testing was performed and the sample worked properly with no leak, occlusion, or damage.The reported issue was not confirmed.A device history record (dhr) review was conducted for lot # 4381330 which indicated all inspections were completed and no issues were noted during manufacture.Note: exact lot number was unknown; possible lot numbers reported were 4381329 and 4381330.

• Brand Name: SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18479897
• MDR Text Key: 333015047
• Report Number: 9617604-2024-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586020319
• UDI-Public: 30610586020319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7047-24
• Device Catalogue Number: 21-7047-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CADD PUMP.