MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION I.V. SOLUTION ADMINISTRATION SETS WITH STOPCOCKS; SET, BLOOD TRANSFUSION

Catalog Number MMC2081B

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944); No Flow (2991)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a theatre administration set for blood and blood components would not flow due to a piece of plastic that blocked the 3-way tap.It was further reported that the piece of plastic ¿was too big to pass through the tap and go towards the patient but it was big enough to occlude the port and damage it¿.The reporter stated that "they could not inject drugs and once the piece of plastic was removed, fluids were observed dripping from the tap".This was observed during priming before being connected to a patient.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 to the photograph using the naked eye which revealed a piece of plastic by the stopcock.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. 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: I.V. SOLUTION ADMINISTRATION SETS WITH STOPCOCKS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12762030
• MDR Text Key: 280581906
• Report Number: 1416980-2021-06629
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MMC2081B
• Device Lot Number: 21F18T701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2021
• 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