MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN STRAIGHT BC; INTRAVASCULAR CATHETER

Model Number	386807
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2020
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.(b)(4).
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc leaked blood.The following information was provided by the initial reporter: after catheter placement, the hcp advanced the catheter and then saw blood leaking before retracting the needle.Blood leakage from the catheter hub was not observed.The customer have never experienced such an incident like this before and would like to know possible issues attributable to product defect as well as to manipulative techniques.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-28.H6: investigation summary: four photos and one sample were received by our quality team for evaluation.From the returned photos and sample, blood was seen in the flashback chamber but no leakage was observed.This is normal after usage of the product, therefore the team was not able to confirm the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc leaked blood.The following information was provided by the initial reporter: after catheter placement, the hcp advanced the catheter and then saw blood leaking before retracting the needle.Blood leakage from the catheter hub was not observed.The customer have never experienced such an incident like this before and would like to know possible issues attributable to product defect as well as to manipulative techniques.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11168154
• Report Number: 8041187-2021-00024
• Device Sequence Number: 19827894
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201717
• 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): 02/26/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 386807
• Device Catalogue Number: 386807
• Device Lot Number: 9165819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1