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

Catalog Number	5C4456
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the sterile packaging of six (6) flexicaps were damaged.The shipping box was delivered damaged and ripped open and it appear that some flexicaps were ripped open a little and others were in question.This was discovered prior to use for peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual devices were not available; however, photographs of the samples were provided for evaluation.Visual inspection of the photos did not identify any abnormalities that could have contributed to the reported condition.The photos showed loose pouched units.There is no damage visible on the pouches and none of the pouches appear to be open.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: FLEXICAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12350806
• Report Number: 1416980-2021-05148
• Device Sequence Number: 20156563
• Product Code: KDJ
• UDI-Device Identifier: 00085412349145
• UDI-Public: (01)00085412349145
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 5C4456
• Device Lot Number: 21D01H25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1