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

Catalog Number SPC4466

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported that the povidone-iodine sponge of a minicap detached from the device.The separation occurred before use.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.This is report 12 of 30.

Manufacturer Narrative

(b)(4).The sample is reported to be available for evaluation but has not yet been received.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.If the sample is received or additional relevant information becomes available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter and the evaluation is complete.A visual inspection was performed and the foam was noted to be separated for the device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3552377
• MDR Text Key: 4102935
• Report Number: 1416980-2014-00432
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: SPC4466
• Device Lot Number: 13E03H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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