MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, ADMIN, HIGH VOL, 1.2 FLTR, INJ SITE, FS, TOTM 15/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7361-24

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the customer could not see recall online messages that involved multiple tubing.It was unknown if there were any adverse patient effects.

Manufacturer Narrative

Device evaluation: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: SET, ADMIN, HIGH VOL, 1.2 FLTR, INJ SITE, FS, TOTM 15/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: 18414088
• MDR Text Key: 331718517
• Report Number: 9617604-2023-00049
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: 15019517191738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7361-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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