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

Catalog Number 9425TRU

Device Problem Disconnection (1171)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) has reached out to customer three times to provide the complaint device for further investigation.A (b)(6) label was also provided to the customer each time.Unfortunately, (b)(4) has not received the complaint device for evaluation.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported the following ¿the needle stayed in the arm when the therapist pulled out the sheath.The sheath came out and left the needle in place, only the needle and nothing else.The needled was pulled out of the patients arm per the therapist fingers, and the patient did not require any further intervention or treatment.Customer also confirmed that the needle was the only thing in the patients arm the needle disconnected from the hub and there was no plastic on the needle.

Manufacturer Narrative

Unfortunately no sample or photograph was submitted for further evaluation.The device history records were reviewed for the two unconfirmed lot numbers and no issues were found.Two years of complaint trends were also reviewed and no trend was detected.The affected needle component is supplied by an external vendor.A supplier corrective action request was issued to this supplier.Without a sample for further evaluation the supplier was able to provide the following information.The specification limit for cannula removal force is a minimum of five pounds.Without a sample for further evaluation the supplier feels the most probable root cause could be related to insufficient epoxy.An epoxy inspection system has been established to avoid this kind of failure.The supplier has also performed a training session with the assembly operators.

• Brand Name: ABG MICRO KIT 1ML 25 GAUGE 5/8" SL KIT
• 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: mindy faber ; 75 n. fairway dr.; vernon hills, IL 60061
• MDR Report Key: 6411813
• MDR Text Key: 70174688
• Report Number: 8030673-2017-00306
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9425TRU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• 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