MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE DISPOSABLES; WARMER, THERMAL, INFUSION FLUID

Model Number	L-370
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.One (1) picture was received for evaluation.It can be observed that the sample had a kink in the tube.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.The most probable cause is that the product became damaged after it left the manufacturing facility.No corrective actions have to be implemented in manufacturing process since it is unlikely that the kink was caused during the manufacturing process.A notification of this complaint to the production personnel was conducted by the quality intern.
Event or Problem Description
It was reported that the physician had to squeeze the bulb on the blood tubing to make the blood infuse faster.The connection line became crimped making it difficult to infuse a bolus of blood to the patient.No patient injury was reported.

• Brand Name: LEVEL 1 HOTLINE DISPOSABLES
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15649919
• Report Number: 3012307300-2022-25654
• Device Sequence Number: 2428419
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: L-370
• Device Catalogue Number: L-370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown