MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI MINICAP PREP KITS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number ARM4226P

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

It was reported that the foam was found to be outside of the cap, but inside the packaging.This was noted before use, just after the package was opened.The minicap was not used by the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.This is report six of six.

Manufacturer Narrative

(b)(4).(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was returned and visually inspected.The minicap was returned not in its original packaging, but all components were present and the set was assembled according to procedure.Although all of the components were present, the sponge was found to be out of the cap and was smaller than usual.The reported event was duplicated when a sponge smaller than specified was assembled into the cap, iodine was applied, and when the cap was moved, the sponge came out of it.The device did not meet product specifications related to this event.The cause of this event was determined to be a manufacturing issue.This was further investigated through a capa.The cause of the reported event was determined to be the size of the sponge provided by a supplier and the handling by operators since the packaged device was being shaken by operators to accommodate the packaging, resulting in the sponge coming out of the cap.As a result, the supplier was notified of the issue and the operators were retrained in order to eliminate the shaking practice.Should additional relevant information become available, a supplemental report will be submitted.Same patient/event as (b)(4).

• Brand Name: MINICAP PREP KITS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; apartado aereo 2446 calle #36,; cali ; CO
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; apartado aereo 2446 calle #36,; cali ; CO
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4946485
• MDR Text Key: 21844456
• Report Number: 1416980-2015-30412
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2015

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: 03/31/2017
• Device Catalogue Number: ARM4226P
• Device Lot Number: SE15CE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1