MAUDE Adverse Event Report: CAREFUSION/BD ABG MICRO 1ML 25 GAUGE 5/8" SL; ARTERIAL BLOOD SAMPLING KIT

Catalog Number 9025TRU

Device Problem Disconnection (1171)

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

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported ¿we are having issues with some of our abg kits.We will have random kits that the needle will separate from the plastic hub.Usually this occurs once we have the needle in the patients arm and we are in the process of withdrawing the device.It is a hazard to the patient and staff not to mention embarrassing¿.The customer reported that there was no patient harm or medical intervention required."the staff expressed they carefully pull the needle out of the patient¿s skin with their fingers and place it in the needle disposal box.It generally leaves a messy area to be cleaned".

Manufacturer Narrative

Follow up submission: no sample was received for evaluation.The device history record for the lot number reported was evaluated and no issues were observed.Two years of complaints were reviewed related to this issue, and no trend was identified.The needle is supplied by an external vendor.The supplier was issued a scar.The supplier stated that the detachment may be caused by an insufficient epoxy at the site of the needle and the hub.The supplier will further determine the root cause and applicable action plan related to this issue.

• Brand Name: ABG MICRO 1ML 25 GAUGE 5/8" SL
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6247078
• MDR Text Key: 64669995
• Report Number: 8030673-2017-00275
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9025TRU
• Device Lot Number: 0000969055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention