MAUDE Adverse Event Report: CAREFUSION/BD TUBING O2 50FT VNL TP W/CRUSH RES 15/CS; TUBING, PRESSURE AND ACCESSORIES

Catalog Number 001306

Device Problem Kinked (1339)

Patient Problem Hypoxia (1918)

Event Date 05/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion has reached out to customer to provide the complaint device for further investigation.The customer indicated that the sample was shipped back to carefusion, along with additional written details regarding the reported event.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

There was a kink in the hose, therefore, no oxygen was received per the patient.End-user stated that his wife has multiple health problems and will likely be readmitted with respiratory issues.He is unsure if her drowsiness was related to her medical condition, or the reported kinked tubing.

Manufacturer Narrative

This reportable event was submitted as a malfunction.Upon further review carefusion/ bd will be reporting this incident as an adverse event requiring intervention.The product code and device code has been corrected.The customer provided the following additional information."the hose was put in service the evening before the kink was discovered".The customer confirmed that there was an adequate service loop.The patients health history includes cpod this is why she requires oxygen at night.Her average pulse ox is in the low 90's.The kink was discovered when the patients pulse ox dropped to 82%.Once the tubing was changed out the patient did recover back to baseline.(b)(4).Carefusion/bd was unable to review the device history record; the lot number was not provided by the customer.One sample was received for evaluation, during visual inspection a mark was observed on the tube, confirming the kink condition.Upon review of the manufacturing procedure carefusion/bd found the correct assembly instruction between the tube and the end connectors; however the kinked condition on tube is likely related to the way the code is coiled.This process is not clearly defined the manufacturing procedure has been updated to specify how to coil the finished good for packaging and shipping.

• Brand Name: TUBING O2 50FT VNL TP W/CRUSH RES 15/CS
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• 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 ; 7149227830
• MDR Report Key: 5781355
• MDR Text Key: 49957179
• Report Number: 8030673-2016-00180
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 001306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention