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

Catalog Number H938176

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a syringe inlet had presented dirt in the connector.This issue was identified during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photograph which observed a dark foreign matter at the inlet female connector and possibly embedded.The reported condition was verified.The cause of the condition could not be determined, however, it is possible it could have occurred during 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 ; 2242702068
• MDR Report Key: 13111862
• MDR Text Key: 282958073
• Report Number: 1416980-2021-07585
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475813
• UDI-Public: (01)00085412475813
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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
• Device Operator: Other
• Device Expiration Date: 05/04/2023
• Device Catalogue Number: H938176
• Device Lot Number: 802978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• 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