MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAO PAULO MINICAP PREP KITS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number HZC4226BN

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event date was asked but unknown.(b)(6).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the packaging of an unspecified number of minicaps was not properly sealed.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: MINICAP PREP KITS
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - SAO PAULO; sao paulo
• Manufacturer (Section G): BAXTER HEALTHCARE - SAO PAULO; av. eng. eusebio stevaux, 2555; sao paulo 04696 -000; BR 04696-000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7688254
• MDR Text Key: 114032698
• Report Number: 1416980-2018-04344
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HZC4226BN
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• 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: N
• Patient Sequence Number: 1