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

Catalog Number ARM4466E

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned and an evaluation was completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed and it noted that the lower seal of the packaging was not complete.There was seal separation in a small portion.The reported event was verified.To identify the cause, the issue was reproduced during machine start up at the silicone buffer change, when it is not positioned properly in its cavity.It was noted that this issue occurred when the machine began working, but then the buffer adjusted into the cavity as performed by the operator.The cause was determined to be related to the manufacturing.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the foil packaging of the minicap was ¿without air¿.There was no patient involvement.No additional information is available.

• Brand Name: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6256104
• MDR Text Key: 64933660
• Report Number: 1416980-2017-00225
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: ARM4466E
• Device Lot Number: SE16HC5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1