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 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that "when the product was set on the hot line and driven, leakage from the connection was confirmed." this occurred during priming, no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

One device was received for investigation.Visual inspection found a crack in the female luer connector.The device was functionally tested.The female luer present a damaged in the connection part.The reported complaint is confirmed.No root cause could be determined.A review of the device history records could not be completed as no lot number was provided by the customer.

• 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: 18974600
• MDR Text Key: 338562098
• Report Number: 9617604-2024-00253
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: L-70
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 03/28/2024
• 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