MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number L-70

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: month and year of event have been provided; day is unknown.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 "the blood transfusion line connection broke and blood leaked." occurred during pre-testing/priming at the facility.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Investigation summary: two (2) photos were attached for evaluation.Picture one (1) shows an l-70 product.Picture two (2) shows a close-up of the proximal end female luer connector which is observed to have a crack.One (1) unit of part number l-70 was received without original package, in used condition.The sample was visually inspected under normal conditions of illumination to detect any cosmetic issue.A crack was found in the female luer connector.To replicate the failure mode an l-70 device was taken to retest in leak test in order to create damage in the female luer.Leak test was performed 3 times in the l-70 device.During the third attempt the female luer presented damage in the connection part; however, it was not similar to the sample reported.To replicate the failure mode an l-70 device was taken to perform leak test without o ring in the piston in order to create damage in the female luer.Circular damage was created in the connection part of the female luer; however, the crack along the female luer could not be replicated.Based on the replication of the failure mode results the crack reported is not attributable to the manufacturing process.The root cause was not determined.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 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: 19130423
• MDR Text Key: 340461693
• Report Number: 3012307300-2024-02704
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)261221(10)4293567
• 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: Health Professional
• Device Catalogue Number: L-70
• Device Lot Number: 4293567
• 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
• Date Device Manufactured: 01/09/2023
• 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