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

Catalog Number 5C4466P

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

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 cracked and leaking iodine.The product was past expiration date.The patient secured the cap to the transfer set and it resulted in an iodine leak.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The lot was manufactured from 10/14/13 to 10/17/13.The actual device was not available; however, a companion sample was received for evaluation.Visual inspection was performed with no defects or cracks noted.Underwater pressure/leak testing was performed with no leak identified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was unable to be replicated in the companion sample.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 - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5236837
• MDR Text Key: 31759134
• Report Number: 1416980-2015-42321
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895631
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 5C4466P
• Device Lot Number: GD895755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• 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