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

Catalog Number ZMC7401

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2014

Event Type  malfunction  

Event Description

It was reported that a stopcock had a leak.The stopcock was placed on the left femoral of the patient and appeared like it had holes or cracks.There was bleeding observed in the patient¿s bed however there was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The customer stated that the device is from one of the three lot numbers: 14g01v195, 14e27v614, or 14e01v554.Lot 14g01v195 was manufactured on july 10, 2014, lot 14e27v614 was manufactured on june 2, 2014, lot 14e01v554 was manufactured on may 22, 2014.The device was received for evaluation.Visual inspection revealed a crack on the frame of the stopcock.A leak test was performed and a leak was observed at the location of the crack.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted for each lot 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 - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4844907
• MDR Text Key: 5945777
• Report Number: 1416980-2015-25265
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/21/2015

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: Other
• Device Catalogue Number: ZMC7401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/15/2015
• 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