MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; STOPCOCK, I.V. SET

Catalog Number 2C6217

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large bore stopcock broke in half as the clinician was removing the stopcock from the packaging.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for sample evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.During visual inspection, it was revealed that the device was broken.The reported condition was verified.The cause of the condition was not determined.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 00705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 00705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5377819
• MDR Text Key: 36340677
• Report Number: 1416980-2016-01414
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/10/2019
• Device Catalogue Number: 2C6217
• Device Lot Number: UR14L10082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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