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

Catalog Number 2C6931

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported that an interlink continu-flo set was coming apart between the stopcock and the manifold during infusion.There is no report of patient/user injury or medical intervention was needed in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Evaluation summary: the used sample was received for evaluation.Visual inspection determined there was no damage to the stopcock or manifold.The luer connections were all checked for proper connection and were then disconnected and reconnected to ensure that adequate connection was possible.No malfunctions were identified.A simulated use test was performed with water by priming the set according to the label.The sample was hung as in the hospital environment, with the stopcock/manifold combination lying on a cart to simulate actual use and checked for disconnection between the stopcock and manifold.No malfunctions were identified when the stopcock and manifold were in this position, as confirmed by all the port caps oriented in the upright position.The stopcock is not supposed to be turned or twisted to the left unless it is being disconnected from the set/manifold.When the stopcock is turned to the left and the manifold is secure, the two components may become disconnected, which is expected by the product design.In addition to the used sample, 96 unused companion samples were received for evaluation.Visual inspection, pressure testing, and simulated use testing were performed on each of the unused samples.The samples all functioned according to product specification.The reported condition was not able to be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4): the lot gr310938 was manufactured july 24, 2013 - july 29, 2013.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device has been received by baxter, but the evaluation has not yet been completed.A follow-up report will be submitted upon completion of evaluation or if additional relevant information becomes available.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3632578
• MDR Text Key: 4181846
• Report Number: 1416980-2014-05794
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/23/2018
• Device Catalogue Number: 2C6931
• Device Lot Number: GR310938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• 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