MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, UNIV ENDS,; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H93821

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that a fluid transfer tube set leaked close to the connection of a repeater pump.The issue was identified during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter phone no (additional): (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured on february 12, 2022 to february 15, 2022 h10: the device was received for evaluation.An unaided visual inspection was performed and did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed and no leak was observed.The reported condition was not verified.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: TUBE SET, STD VOL, UNIV ENDS,
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• 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 60073 ; 2242702068
• MDR Report Key: 17203582
• MDR Text Key: 318130020
• Report Number: 1416980-2023-03153
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H93821
• Device Lot Number: 60348508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/21/2023
• 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