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

Catalog Number ABC4466BA

Device Problems Unsealed Device Packaging (1444); Product Quality Problem (1506)

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

Event Date 07/31/2022

Event Type  malfunction  

Event Description

It was reported that two (2) minicaps had no iodine inside.This was observed before use of the devices for peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: b5, g3, e1 information, f10/h6: medical device problem codes and component codes (add codes), and h4.B5: additionally, it was reported that the packaging (overpouch) of the two (2) minicaps was also opened (previously omitted in the initial report).E1: initial reporter address: (b)(6).G3: the previous date should have been july 31, 2022 (not august 03, 2022).H10: the actual devices were not available; however, photographs of the samples were provided for evaluation.A visual inspection of the photos identified two (2) packages that were opened.However, the characteristic mark of having formed a seal between the formable paper and the printed paper was present; both identified the fingerprint of the adhesive that was white which indicates the seal of the package was complete when it was released.Another photo identified a minicap with a yellowish coloration inside the sponge which is characteristic of the absorption of iodopovidone; during the manufacturing process, the sponge is white.The amount of iodopovidone could not be verified.Therefore, the reported condition of no iodine could not be verified.The reported condition of opened packaging was verified.The cause of the opened packaging could not be determined.Fourteen (14) retained samples were also evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the retained samples.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
• Manufacturer (Section G): BAXTER HEALTHCARE - CUERNAVACA; calle 50 metros; civac, jiutepec morelos 62578 ; MX 62578
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15306395
• MDR Text Key: 302411015
• Report Number: 1416980-2022-04471
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412353036
• UDI-Public: (01)00085412353036
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: ABC4466BA
• Device Lot Number: M22D28B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2022
• 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
• Patient Sex: Female