MAUDE Adverse Event Report: QUEST MEDICAL, INC Q2 IV EXTENSION SET; IV EXTENSION SETS

Model Number 95906

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

The facility was contacted several times to request for information about the reported incident and responses received indicate the facility has no knowledge of the incident.No information has been provided by the facility to aid in the investigation.No complaint sample was returned for evaluation.The dhr review did not identify any anomalies related to the reported complaint condition.A follow up medwatch will be submitted if additional information is received.

Event Description

A copy of a medwatch was received by quest medical on 6/28/2018.The medwatch states that a nurse was flushing the line and there was a "sudden resistance" at which time the cap came off and fluid sprayed out of the pivo connection port into her eye, face and arm.

Manufacturer Narrative

Additional information received during an on site visit to the user facility indicates that the incident occurred.The user facility stated that during the procedure, the nurse felt resistance but continued to flush the line at which time, the fluid sprayed through the q2 device.A suspected cause of the complaint condition is an occluded iv catheter where the potency of the catheter may not have being verified before injection in line with hospital protocols.Review of the manufacturing process did not show any process anomaly at the time of investigation.During manufacturing, the parts are aql sampled and inspected for leak.All the inspection equipment were found to be calibrated.The root cause of the incident is not manufacturing related.

• Brand Name: Q2 IV EXTENSION SET
• Type of Device: IV EXTENSION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7696739
• MDR Text Key: 114619653
• Report Number: 1649914-2018-00068
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 95906
• Device Lot Number: 054872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention