MAUDE Adverse Event Report: COVIDIEN ANG WNG 23G BCS W/LUER ADPTR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225307
Medical Device Problem Code	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 complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that there was an issue with pull tab.Additional information received from the customer stated that when the nurses are done with the collection, they pull the tabs to secure the needle and if they push on the butterfly it allows the needle to release from the piece of metal that is supposed to hold it.The nurse has noticed that the safety on this butterfly is failing.The customer further stated that it appears to be the piece of metal that is supposed to hold the needle after use is not properly bent to contain the needle.There was no patient harm reported.

• Brand Name: ANG WNG 23G BCS W/LUER ADPTR
• 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: 11382183
• Report Number: 1282497-2021-09938
• Device Sequence Number: 17012447
• Product Code: FOZ
• UDI-Device Identifier: 10884521013391
• UDI-Public: 10884521013391
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: No Information
• Device Model Number: 8881225307
• Device Catalogue Number: 8881225307
• Device Lot Number: 202740004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1