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

Catalog Number	386801
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that bd cathena¿ safety iv catheter needle did not retract all the way.This was discovered during use.The following information was provided by the initial reporter: material no.: 386801.Batch no.: 8144026.It was reported that the needle did not retract all the way leaving the needle exposed.Per complaint form: clinical resource nurse contacted me via email and sent in pictures of cathena showing that the needle did not fully retract leaving the needle exposed.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received by our quality team for evaluation.Upon visual inspection, it was observed that the needle did not retract fully leaving the needle exposed; therefore, the failure can be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, it was not clear through the photos what caused the needle to not fully retract; therefore the root cause cannot be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that bd cathena¿ safety iv catheter needle did not retract all the way.This was discovered during use.The following information was provided by the initial reporter: material no.: 386801; batch no.: 8144026.It was reported that the needle did not retract all the way leaving the needle exposed.Per complaint form: clinical resource nurse contacted me via email and sent in pictures of cathena showing that the needle did not fully retract leaving the needle exposed.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9111606
• Report Number: 8041187-2019-00754
• Device Sequence Number: 16260448
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 386801
• Device Lot Number: 8144026
• Initial Date Received by Manufacturer: 09/08/2019
• Supplement Date Received by Manufacturer: 09/08/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other