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

Catalog Number H938751

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging of fifteen micro-volume inlets (w/large bore spike) were not sealed.The issue was identified before use.There was no patient involvement.

Manufacturer Narrative

H4: device manufacture date ¿ the lot was manufactured between december 6th, 2021 and december 7th, 2021.H10: fifteen (15) devices were received for evaluation.A visual inspection was performed, and it was noted that the bottom side of the primary packaging was not sealed on all the returned samples.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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
• 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: 15661968
• MDR Text Key: 304879857
• Report Number: 1416980-2022-05670
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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
• Device Operator: Other
• Device Catalogue Number: H938751
• Device Lot Number: 60337465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/17/2023
• 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