MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAO PAULO MINICAP PREP KITS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number AZC4226FN

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a minicap was damaged.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: additional information from customer contact: the patient reported that he does not remember the exactly date of occurence, however, he informed that he only observed the crack after connecting the minicap to the set.The device was received for evaluation.A visual inspection was performed and found that the minicap was cracked.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.An ncr has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP PREP KITS
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - SAO PAULO; av. engenheiro eusebio; stevaux; sao paulo 84696 000; BR 84696000
• Manufacturer (Section G): BAXTER HEALTHCARE - SAO PAULO; av. engenheiro eusebio stevaux; sao paulo 84696 000; BR 84696000
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5481032
• MDR Text Key: 39705396
• Report Number: 1416980-2016-04597
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/25/2018
• Device Catalogue Number: AZC4226FN
• Device Lot Number: PS49A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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