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

Catalog Number ARC2220P

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/23/2014

Event Type  malfunction  

Event Description

It was reported that an access set had a leak from its "three-way clamp." this reportedly occurred during infusion of an unspecified drug.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Baxter received the sample for evaluation.A visual inspection was performed and no obvious defects were found.An underwater leak test was performed and no leakage was identified from the 3-way clamp or stopcock.The reported condition was not verified.However, a leak from the y site was identified and will be captured and reported in (b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 - CALI; apartado aereo 2446; calle #36; cali ; CO
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; apartado aereo 2446; calle #36; cali ; CO
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4347810
• MDR Text Key: 5171943
• Report Number: 1416980-2014-46672
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: ARC2220P
• Device Lot Number: SE14GM6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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