MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INLET, MICROVOL, VENTED SPIKE; SET, I.V. FLUID TRANSFER SET

Catalog Number H938751

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a disconnection between the tubing and spike of a micro-volume inlet (w/large bore spike) which resulted in a leak.The issue was identified during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on october 14, 2022- october 18, 2022.H10: the device was received for evaluation.Unaided eye visual inspection was performed and the inlet spike was observed detached from the inlet tubing.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition could not be determined, however the most likely cause was due to inadequate or lack of solvent being applied to the outer diameter of the tube when it was inserted to the spike in the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INLET, MICROVOL, VENTED SPIKE
• Type of Device: SET, I.V. FLUID TRANSFER SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16230158
• MDR Text Key: 308528526
• Report Number: 1416980-2023-00110
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K903159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938751
• Device Lot Number: 60325014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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