MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 INTRAVENOUS ADMINISTRATION SET; IV ADMINISTRATION SET

Model Number 9527B

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No patient complications were reported as resulting from the alleged event.The device will be evaluated and a follow-up medwatch will be submitted if additional information becomes available.

Event Description

The report received from the customer states that the top left cap of the manifold broke off.

Manufacturer Narrative

The complaint could not be confirmed as manufacturing related.A body side load test was conducted on the sample received to evaluate weld integrity and the sample passed the specification of 6.65ib-in.A dhr review could not be conducted since no lot number was provided by the customer but a process review was conducted and no anomalies were identified.The device is inspected a 100% for weld integrity during manufacturing and is also subjected to a 100% leak test.After manufacturing, the device is also tested for side load force.The root cause of the issue is unknown.

• Brand Name: Q2 INTRAVENOUS ADMINISTRATION SET
• Type of Device: IV ADMINISTRATION SET
• 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: 7022608
• MDR Text Key: 92872620
• Report Number: 1649914-2017-00092
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

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: Nurse
• Device Model Number: 9527B
• Device Catalogue Number: 9527B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1