MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386807
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc needle was difficult to disengage.The following information was provided by the initial reporter: this is a report about difficult needle disengagement.According to the customer¿s report, the hcp attempted to withdraw the needle but felt resistance and could not withdraw the needle.The hcp completed catheter placement with another cathena.
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc needle was difficult to disengage.The following information was provided by the initial reporter: this is a report about difficult needle disengagement.According to the customer¿s report, the hcp attempted to withdraw the needle but felt resistance and could not withdraw the needle.The hcp completed catheter placement with another cathena.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-27.Investigation summary: (b)(4)photos and (b)(4) sample was received by our quality team for evaluation.From the returned photos and sample, the safety mechanism device was observed to be partially activated with the adapter attached.During inspection of the cannula, a dent was observed.A device history record could not be evaluated as the lot number is unknown.A major dent was observed on the cannula from the returned sample, based on the location of the dent, it may have occurred at the pick and place station.A simulation was performed and the team was unable to simulate the defect to get the major dent on the cannula as seen on the sample.However, it is suspected that the dent on the cannula could be due if the gripper on the pick and place station was misaligned.A digital angle meter has been implemented to check the gripper alignment after setup.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family:cathena.Device failure:needle disengagement difficult.
Event or Problem Description
No additional information.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11336250
• Report Number: 8041187-2021-00102
• Device Sequence Number: 10983741
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

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: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 05/22/2025
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/24/2021; 05/22/2025
• 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