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

Model Number	386863
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 unspecified bd cathena¿ iv catheters' safety shield mechanisms failed to activate during use.The following information was provided by the initial reporter: "i have 2 cathena iv catheters in my office from er that the safety feature didn¿t deploy.When they pulled the needle out, the hub didn¿t slide into place over the end of the needle.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5.Describe event or problem: device name updated.D4.Medical device material #:386863.D4.Medical device lot #:1324334.D4 unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 30nov 2024.D4.Medical device manufacturer: becton dickinson medical (singapore).G1.Manufacturing location: becton dickinson medical (singapore).G5.Pma / 510(k)# : k201717.H4.Device manufacture date: 20 nov 2021.H6.Investigation summary: based on device history record review, no abnormality was observed during the production of the affected batches.From the returned photo, the safety mechanism was not fully activated and there was blood at the needle hub flashback chamber.However, unable to evaluate from the photo whether there is dent on the cannula or safety activation components failure/damage that resulted in the safety activation failure.As the actual sample was not returned for investigation, actual root cause could not be established.
Event or Problem Description
It was reported that 2 bd cathena¿ safety iv catheters' safety shield mechanisms failed to activate during use.The following information was provided by the initial reporter: "i have 2 cathena iv catheters in my office from er that the safety feature didn¿t deploy.When they pulled the needle out, the hub didn¿t slide into place over the end of the needle.".

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14436510
• Report Number: 2243072-2022-00702
• Device Sequence Number: 14729185
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 386863
• Device Catalogue Number: 386863
• Device Lot Number: 1324334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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