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

Model Number	386810
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd cathena¿ iv catheter safety mechanism will not activate and cause a needle stick injury.The following information was provided by the initial reporter: during the insertion of the 20g catheter, the safety device did not work.The nurse therefore pricked herself.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 27-feb-2023.H6: investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The sample was returned without the packaging and the safety mechanism was not activated.The reported issue of safety shield activation failure (catheter) was not confirmed upon inspection and testing of the sample.Analysis of the sample showed that there were no abnormalities or damages present.The safety mechanism was tested by manual activation and the sample performed properly.Bd was unbale to determine a root cause for the reported incident since the defect was not confirmed during the examination of the returned sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported that the bd cathena¿ iv catheter safety mechanism will not activate and cause a needle stick injury.The following information was provided by the initial reporter: during the insertion of the 20g catheter, the safety device did not work.The nurse therefore pricked herself.

• Brand Name: BD CATHENA¿ 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16496448
• Report Number: 8041187-2023-00080
• Device Sequence Number: 12374995
• Product Code: FOZ
• UDI-Device Identifier: 00382903868100
• UDI-Public: (01)00382903868100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 386810
• Device Catalogue Number: 386810
• Device Lot Number: 2141060
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown