MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number L-70

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that during priming, the tubing was leaking from the connection.It was suspected by the reporter that the adhesion was poor.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Month and year of event have been provided; day is unknown.Operator of device is unknown, no information has been provided to date.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 reportable information becomes available.

Manufacturer Narrative

Investigation summary: one (1) picture was attached for evaluation.The picture shows an l-70 product out of its original packaging.One (1) unit of part number l-70 was received with original package, in used condition.The sample was visually inspected under normal conditions of illumination to detect any cosmetic issue.In the unit received, it was detected that the injection port "y" and the 8" tube are not connected, no solvent marks were found, so the cause of the failure mode is due to the absence of solvent in the unit.The reported failure mode is confirmed.Based on the rmp, the root cause is operator error in not putting solvent on the joint.No action was taken by the manufacturer.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.D4.Unique identifier (udi) #: (b)(4).

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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: 18808207
• MDR Text Key: 337078334
• Report Number: 9617604-2024-00191
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)270104(10)4297509
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• 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: 04/03/2024

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: Other
• Device Catalogue Number: L-70
• Device Lot Number: 4297509
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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