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

Catalog Number ABC4466BA

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a minicap had a damaged package; further described as "individual pouch opened".This was observed during use for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information in h3, h4, h6.H10: the actual device was not available; however, photographs were received for evaluation.Visual inspection of the photographs observed that the packaging was opened and a part of the packaging seal was detached.The reported condition was verified.The cause of the condition could not be determined by the photographs.As a result, fourteen (14) retention samples were examined.Upon visual inspection of the retention samples, no open or poorly sealed packages were identified.No deviations were identified that could contribute to the reported condition.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: 10405336
• MDR Text Key: 202865204
• Report Number: 1416980-2020-04961
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412353036
• UDI-Public: (01)00085412353036
• Combination Product (y/n): Y
• 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: 09/15/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: ABC4466BA
• Device Lot Number: M20E12A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIANEAL SOLUTION