MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; CATHETER, INTRAVASCULAR

Model Number	386863
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd cathena¿ safety iv catheter needle would not separate from hub.The following information was provided by the initial reporter: i was supervising a student placing an a 20 g iv.Before we started, i educated her on making sure to loosen the top of the catheter from the bottom to make sure they separated ok.I watched her perform this step before she began.She placed the iv and got blood return.When she attempted to separate the needle from the hub, they would not separate.Blood also flashed and pooled in the back of the iv past the front spring.I assisted her and attempted to remove it and when it finally separated, the needle came back without the safety on.Luckily i was not stuck by the needle, but it was a close call!.
Additional Manufacturer Narrative
Investigation summary: two samples were received by our quality team for evaluation.The sample was observed with the safety mechanism not activated.No dent was observed on the cannula.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 that while using bd cathena¿ safety iv catheter needle would not separate from hub.The following information was provided by the initial reporter: i was supervising a student placing an a 20 g iv.Before we started, i educated her on making sure to loosen the top of the catheter from the bottom to make sure they separated ok.I watched her perform this step before she began.She placed the iv and got blood return.When she attempted to separate the needle from the hub, they would not separate.Blood also flashed and pooled in the back of the iv past the front spring.I assisted her and attempted to remove it and when it finally separated, the needle came back without the safety on.Luckily i was not stuck by the needle, but it was a close call!.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR
• 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: 14437066
• Report Number: 8041187-2022-00258
• Device Sequence Number: 20110272
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: 00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 11/30/2024
• Device Model Number: 386863
• Device Catalogue Number: 386863
• Device Lot Number: 1324334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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