MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number ABC4466BA

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging of a minicap was damaged; further described as "the seal was open." this was found before use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

One (1) actual sample was received for evaluation.A visual inspection noted crushed aluminum and a three centimeter opening on one side of the package.It was identified that a cut was made to detach the package from the pattern; rather than separating the package by means of the dotted lines.Therefore, the seal was weakened by the cut.It was further observed that the white mark of the seal remained on the entire periphery of the package, including the area where the cut was made.The reported condition of opening was verified.The exact cause could not be determined, although it was likely to be a result of user handling.Fourteen (14) retention samples were evaluated.A visual inspection was performed with no issues noted.All of the packages were sealed and no openings were identified.Therefore, all of the retention samples complied with the quality specifications established for the product.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: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9498051
• MDR Text Key: 172221332
• Report Number: 1416980-2019-07030
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412353036
• UDI-Public: (01)00085412353036
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: ABC4466BA
• Device Lot Number: M19K03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1