MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 22 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number	386806
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cathena safety iv catheter bd multiguard technology 22 ga 1.00 in a needle would not retract with the safety mechanism.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer's report, after venipuncture, the hcp attempted to retract the needle but the safety mechanism was not activated.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 03-mar-2022.Investigation summary three photos and one sample were received by our quality team for evaluation.From the photos, the safety mechanism was observed to not be activated, the needle also appeared to be bent.The sample was observed with the safety mechanism not activated and the needle bent.The tip shield was manually pushed through the cannula and was able to be activated properly, no safety activation failure was observed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported while using bd cathena safety iv catheter bd multiguard technology 22 ga 1.00 in a needle would not retract with the safety mechanism.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer's report, after venipuncture, the hcp attempted to retract the needle but the safety mechanism was not activated.

• Brand Name: BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 22 GA 1.00 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13638868
• Report Number: 8041187-2022-00105
• Device Sequence Number: 11293677
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: 00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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 Expiration Date: 07/31/2024
• Device Model Number: 386806
• Device Catalogue Number: 386806
• Device Lot Number: 1207012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• Patient Sex: Unknown