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

Catalog Number 6AC4466

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the sponge was completely separated from the minicap.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: the device was received for evaluation.A visual inspection was performed and found the iodine sponge to be outside of the minicap. a batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.The reported issue was verified; however, the cause could not be determined.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 - GUANGZHOU; jiao yuan road, dong ji indust; guangzhou 51073 0; CH 510730
• Manufacturer (Section G): BAXTER HEALTHCARE - GUANGZHOU; jiao yuan road, dong ji indust; guangzhou 51073 0; CH 510730
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5335681
• MDR Text Key: 35176595
• Report Number: 1416980-2015-45921
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 6AC4466
• Device Lot Number: GM1402011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2016
• 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