MAUDE Adverse Event Report: MCKESSON IV SAFETY BLUE WING 22GA X1.0IN; INTRAVASCULAR CATHETER

Model Number	192-PB221W
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that mckesson iv safety blue wing 22ga x1.0in had a retraction failure.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that 2 iv catheters did not retract when button was pushed.
Event or Problem Description
It was reported that mckesson iv safety blue wing 22ga x1.0in had a retraction failure.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that 2 iv catheters did not retract when button was pushed.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-13.Investigation summary: physical samples were received and an investigation was performed.Our quality engineer inspected the samples submitted for evaluation.Bd received thirty-seven unopened units.The thirty-seven units were removed from their packages and visually inspection for any damage to the grip, button, hub, and needle.The units were also inspected for gel or spring defects that might interfere with needle retraction.No damage or defects were observed in any of the units.The units were then tested for needle retraction failure.All thirty-seven units retracted as expected.Bd was unable to confirm the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that mckesson iv safety blue wing 22ga x1.0in had a retraction failure.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that 2 iv catheters did not retract when button was pushed.

• Brand Name: MCKESSON IV SAFETY BLUE WING 22GA X1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12240034
• Report Number: 1710034-2021-00624
• Device Sequence Number: 3532082
• Product Code: FOZ
• UDI-Device Identifier: 10612479250182
• UDI-Public: 10612479250182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 192-PB221W
• Device Catalogue Number: 380323
• Device Lot Number: 0184240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 10/04/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/08/2021; 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1