MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER

Catalog Number H938176

Device Problem Contamination (1120)

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

Event Date 03/03/2024

Event Type  malfunction  

Event Description

It was reported that a black particle was observed in a syringe inlet near the connection port.This was observed during preparation, when starting to connect the tubing to a syringe.A new inlet was obtained to continue setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to d9, h3, h6, and h10: h10: the device was received for evaluation.An unaided eye visual inspection under normal room conditions was performed, and a dark foreign matter at the inlet female connector area of the sample was observed.A visual inspection under magnification was performed, and an embedded dark spot at the inlet female connector that appeared completely encapsulated was observed.The reported condition was verified.The cause of the reported condition could not be determined; however, was most likely due to 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: SYRINGE INLET, NON-STERILE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLASTICOS Y MATERIAS PRIMAS PYMPSA; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18990950
• MDR Text Key: 338789347
• Report Number: 1416980-2024-01389
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475813
• UDI-Public: (01)00085412475813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: H938176
• Device Lot Number: 803668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/24/2024
• 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
• Treatment: NA.