MAUDE Adverse Event Report: COVIDIEN ANGEL WNG 23GX3/4X12IN TUBING; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225190
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that when they tried to close the needle after withdrawing it from the patient¿s arm, the needle popped off from the tubing while they were trying to engage the safety lock.They were unable to safely close the needle.Blood was dripping from the tubing and from the disengaged needle.They had to carry it to the sharps bin uncovered.The issue did not compromise patient care as the draw was already completed.
Event or Problem Description
The customer reported that when they tried to close the needle after withdrawing it from the patient¿s arm, the needle popped off from the tubing while they were trying to engage the safety lock.They were unable to safely close the needle.Blood was dripping from the tubing and from the disengaged needle.They had to carry it to the sharps bin uncovered.The issue did not compromise patient care as the draw was already completed.Additional information provided on 29-apr-2021 stated that it was the colored plastic wing piece that detached from the tubing, not the needle.The customer also stated that once the safety lock was engaged, the needle was not secure; the wings were still able to move back and forth.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr could not be reviewed because the lot number was not available.A box of brand-new samples was received at the manufacturing facility for evaluation.Visual and functional inspection was performed, and no failure was found.Samples were reviewed by the team and no issues were found.The pull test was performed according to procedure and found within specification and tolerance.The reported failure mode will be treated as not confirmed because after evaluation no root cause could be found related to the manufacturing/production process.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: ANGEL WNG 23GX3/4X12IN TUBING
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11741366
• Report Number: 1282497-2021-10128
• Device Sequence Number: 3104775
• Product Code: FOZ
• UDI-Device Identifier: 10884521013018
• UDI-Public: 10884521013018
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2021

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: Health Professional
• Device Model Number: 8881225190
• Device Catalogue Number: 8881225190
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 04/08/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 04/29/2021; 07/30/2021
• Patient Sequence Number: 1