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

Model Number	386815
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed to activate.There was no report of patient impact.The following information was provided by the initial reporter: we're having trouble with bd's neoflon iv needles.After inserting the neoflon, withdraw the needle leaving only the cannula in the patient's vessel.In this case, the safety mechanism spring remained in the cannula.
Additional Manufacturer Narrative
Date of event is unknown; awareness date 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 while using bd cathena safety iv catheter the safety mechanism failed to activate.There was no report of patient impact.The following information was provided by the initial reporter: we're having trouble with bd's neoflon iv needles.After inserting the neoflon, withdraw the needle leaving only the cannula in the patient's vessel.In this case, the safety mechanism spring remained in the cannula.
Additional Manufacturer Narrative
H.6.Investigation: two photos and thirteen samples, one with open packaging and twelve with sealed packaging, were received by our quality team for evaluation.From the photo, the safety mechanism was observed to be activated.The team also observed that a few catheter adapters from the neoflon pro safety non-blood control (bc) catalog 391662 and cathena bc catalog 386815 were compared.The non-blood control (bc) catheter adapters do not have a spring, actuator, and septum, while the blood control (bc) have a spring, actuator, and septum.The sample in open packaging was observed with the safety mechanism activated.The rest of the twelve samples in sealed packaging were subjected to the manual safety activation test.All samples passed the testing.A device history record review found no non-conformances associated with this issue during production of this batch.In the customer verbatim, the customer mentioned ¿safety mechanism spring remained in the cannula¿, but the spring in adapter is part of the blood control (bc) feature of this cathena catalog.Therefore, no nonconformance was found.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed to activate.There was no report of patient impact.The following information was provided by the initial reporter: we're having trouble with bd's neoflon iv needles.After inserting the neoflon, withdraw the needle leaving only the cannula in the patient's vessel.In this case, the safety mechanism spring remained in the cannula.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-may-2022.H6: investigation summary two photos and thirteen samples, one with open packaging and twelve with sealed packaging, were received by our quality team for evaluation.From the photo, the safety mechanism was observed to be activated.The team also observed that a few catheter adapters from the neoflon pro safety non-blood control (bc) catalog 391662 and cathena bc catalog 386815 were compared.The non-blood control (bc) catheter adapters do not have a spring, actuator, and septum, while the blood control (bc) have a spring, actuator, and septum.The sample in open packaging was observed with the safety mechanism activated.The rest of the twelve samples in sealed packaging were subjected to the manual safety activation test.All samples passed the testing.A device history record review found no non-conformances associated with this issue during production of this batch.In the customer verbatim, the customer mentioned ¿safety mechanism spring remained in the cannula¿, but the spring in adapter is part of the blood control (bc) feature of this cathena catalog.Therefore, no nonconformance was found.

• 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 ; 8015296192
• MDR Report Key: 14317957
• Report Number: 8041187-2022-00237
• Device Sequence Number: 4586657
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: 00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 06/14/2022

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: 12/31/2022
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: 9331601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 06/14/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/13/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2019
• 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