MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE; SEE H10

Catalog Number 2C4950

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported that a mini-bag plus docking assist tool had a worn down or broken ¿plastic part that coats the metal bar which assists in docking the vial onto a mini-bag¿.The reporter stated that this caused ¿the docking assist bar to push metal against glass¿, resulting in the bottom of a vial being shattered during use of the device by a pharmacy technician (pt).The vial used was a non-baxter product, and the mini-bag used was a baxter product containing 50 cc of 5% dextrose in water.The reporter indicated that the vial and mini-bag had no obvious damage prior to the event.A glass shard got into the pt's eye; however, it was safely removed, and there was no injury associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Approximate patient age in years: (b)(6).Common device name: equipment, laboratory, general purpose, labeled or promoted for a specific medical use.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device lot was manufactured between the dates 5/1/14 and 5/2/14.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.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection noted that the plastic on the cradle where the vial is connected to the vial adapter and bag was broken, causing the metal screws to be exposed.The reported condition was verified.The cause of the reported shattering of the vial was determined to be the user electing to use the device despite it being "worn down/broken for some time".Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: IVT DISPOSABLE
• Type of Device: SEE H10
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4673246
• MDR Text Key: 5606067
• Report Number: 1416980-2015-15720
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2019
• Device Catalogue Number: 2C4950
• Device Lot Number: GD897009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INVANV VIAL, MANUFACTURED BY MERCK