MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386804
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that cathena 20gx1.25in straight bc safety mechanism would not disengage.The following information was provided by the initial reporter: this is a report about a failure to decouple.The customer reported as follows: after advancing the catheter, the hcp pulled the grip but the white component within the grip was not separated from the catheter.
Event or Problem Description
It was reported that cathena 20gx1.25in straight bc safety mechanism would not disengage.The following information was provided by the initial reporter: this is a report about a failure to decouple.The customer reported as follows: after advancing the catheter, the hcp pulled the grip but the white component within the grip was not separated from the catheter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-22.H6: investigation summary: three photos and one sample were received by our quality team for investigation.From the returned photos and sample, the safety mechanism device was observed to be fully activated.The safety mechanism of the actual sample was exercised and no safety mechanism failure was observed.Therefore, the team was unable to confirm the customer experience.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.

• Brand Name: CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11312227
• Report Number: 8041187-2021-00089
• Device Sequence Number: 19760804
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/18/2021

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: 386804
• Device Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1