MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INLET, MICROVOL,VENTED SPIKE,

Catalog Number H938751

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported that the tubing of micro-volume inlet had disconnected from the hard plastic spike.This issue was identified during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: update "there was no report of patient injury or medical intervention associated with this event." to "there was no patient involvement." the issue occurred before connecting the device to other products.H4: the lot was manufactured from august 31, 2021 - september 01, 2021.H10: the device was received for evaluation.Unaided visual inspection was performed which observed the spike was detached from the tubing of the inlet.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to an inadequate or lack of solvent being applied to the tube during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.This issue was found prior to connection to other products and not associated with leak, accuracy or contamination issues; therefore, it is not likely to cause or contribute to a death or serious injury.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INLET, MICROVOL,VENTED SPIKE,
• Type of Device: INLET, MICROVOL,VENTED SPIKE,
• 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 ; 2242702068
• MDR Report Key: 15534363
• MDR Text Key: 305359686
• Report Number: 1416980-2022-05266
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K903159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938751
• Device Lot Number: 60316144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• 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