MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION 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 12/01/2023

Event Type  malfunction  

Event Description

It was reported that during testing, there was liquid leakage.The device could not be used.The event occurred in end of (b)(6) 2023.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.D5: 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) unit of part number l-70 was received with original package, in used condition.Two (2) photos were included for evaluation; picture one shows the l-70 product with original packaging.Picture two (2) shows a leak at the junction of the tube and the return connector.The sample was visually inspected at a distance of 12¿ to 16¿ under normal conditions of illumination to detect sample conditions that could cause functional issues.The received unit was observed to present delamination in joint between the connector and tube.A leak test was performed based on the mp l-70 manufacturing procedure.The unit failed the leak test.The reported failure mode is confirmed.Based on the analysis on the returned unit, and review of the mitigations during the manufacturing process, the root cause of the lack of solvent.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.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION 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: 18626724
• MDR Text Key: 334614433
• Report Number: 9617604-2024-00092
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)270103(10)4293568
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 4293568
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2023
• 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