MAUDE Adverse Event Report: CATHENA 20GX1.00IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386803
Medical Device Problem Codes	Break (1069); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0118340, medical device expiration date: 2023-04-30, device manufacture date: 2020-04-27.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 cathena 20gx1.00in straight bc catheter separated and the safety mechanism would not activate on 2 occasions.The following information was provided by the initial reporter: on 2 occasions, during the care carried out by the nurse the secure kt did not retract following the installation of the infusion leaving the needle appear.During a blood sample at the time of the catheter installation and the vacutainer delivery, the vacutainer adapter disadapts from the catheter.
Event or Problem Description
It was reported that cathena 20gx1.00in straight bc catheter separated and the safety mechanism would not activate on 2 occasions.The following information was provided by the initial reporter: on 2 occasions, during the care carried out by the nurse the secure kt did not retract following the installation of the infusion leaving the needle appear.During a blood sample at the time of the catheter installation and the vacutainer delivery, the vacutainer adapter disadapts from the catheter.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received by our quality team for evaluation.From the photo, it was observed that the product shown is not a bd tuas cathena product.For the safety shield activation failure, a device history record could not be evaluated as the lot number is unknown.For the catheter separating from the adapter, a device history record review found no non-conformances associated with this issue during production of this batch.As no sample was received for investigation, the root cause could not be established.H3 other text : see h.10.

• Brand Name: CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12173725
• Report Number: 8041187-2021-00592
• Device Sequence Number: 1533442
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 386803
• Device Catalogue Number: 386803
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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