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

Model Number	386803
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism did not properly engage.There was no report of patient impact.The following information was provided by the initial reporter: safety did not engage when inserting cathena.It happened with 2 20g that were from the same lot# as well as an 18g.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.E.1.Address information was not able to be obtained, therefore, nj was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 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 the safety mechanism did not properly engage.There was no report of patient impact.The following information was provided by the initial reporter: safety did not engage when inserting cathena.It happened with 2 20g that were from the same lot# as well as an 18g.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 27-sep-2023.H.6.Investigation summary: our quality engineer inspected the 2 actual sample and the 44 representative samples submitted for evaluation.The reported issue of safety shield activation failure was not confirmed upon inspection of the samples.From the returned actual samples, no dent was observed on the cannula that would obstruct the movement of the tip shield for safety activation.There was also no damage to the v-clip and washer.The safety mechanism of the returned sample was able to be manually activated; no safety activation failure was observed.All the representative samples passed safety activation test.All inspections passed with no defects observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the samples.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism did not properly engage.There was no report of patient impact.The following information was provided by the initial reporter: safety did not engage when inserting cathena.It happened with 2 20g that were from the same lot# as well as an 18g.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• 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 ; 8448235433
• MDR Report Key: 17260127
• Report Number: 8041187-2023-00316
• Device Sequence Number: 12239838
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2023

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 Model Number: 386803
• Device Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 10/23/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/18/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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