MAUDE Adverse Event Report: CARDINAL HEALTH BULB IRRIG SYRINGE STERILE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 67000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967)

Event Date 10/24/2022

Event Type  Injury  

Event Description

The customer reported that the clear plastic part of the ball suction came off the ball and fell onto the patient's cord.Additional information received on 28nov2022 stated that the patient underwent a cervical laminectomy, so the spinal cord (covered by dura) was exposed and unprotected by the bone.The entire clear piece (syringe) filled with normal saline separated from the green rubber ball and fell onto the exposed dura/spinal cord.It was immediately removed from the surgical field.There was a decline in the neuromonitoring during the case and they had to elevate the blood pressure to maps > 85.The patient did have some postoperative weakness which has now resolved.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause.However, a quality alert was issued to the production personnel for awareness notification and a corrective and a corrective and preventive action has been initiated to address the reported issue.

• Brand Name: BULB IRRIG SYRINGE STERILE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15953316
• MDR Text Key: 305241045
• Report Number: 9612030-2022-03491
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10884521007994
• UDI-Public: 10884521007994
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 67000
• Device Catalogue Number: 67000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention