MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 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 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: lot number, udi, expiration date, and h4: manufacture date are unknown; no lot number 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.

Event Description

It was reported that there was a water leak, and the device became unusable.The event occurred in (b)(6)2024.This occurred during infusion.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

H3 and h6.Evaluation codes: updated.Two (2) photos were received for evaluation.Picture, one shows the device, picture two shows a leak in the return connector.One device sample was received without original package, in used condition.Per visual inspection, delamination is observed at the junction of the return connector and the tube which could cause leakage.A functional leak test was performed in which the device failed.The complaint was confirmed.Based on the analysis the root cause was the lack of solvent during manufacturing.Awareness was made to operation personnel and the issue will be monitored for threshold or escalation.A device history record (dhr) review could not be performed as the lot number was unknown.D4 - unique identifier (udi) #.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19130453
• MDR Text Key: 340451810
• Report Number: 3012307300-2024-02705
• Device Sequence Number: 1
• Product Code: LGZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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