MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 22GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Model Number	386813
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 22gx1.00in winged bc was damaged and leaked.The following information was provided by the initial reporter: the new blue catheters cause blood to stagnate in the area just emerging from the puncture site.This is an infectious risk.To limit the risk of infection, the nurses have to change these catheters sometimes daily, causing pain and discomfort for the patients and increasing the risk of infection for the patient.
Additional Manufacturer Narrative
H6: investigation summary: one photo and one adapter was received by our quality team for evaluation.From the returned photo, leakage was observed at the insertion site.The returned sample was subjected to the cathena leak test and no leakage was observed.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 22gx1.00in winged bc was damaged and leaked.The following information was provided by the initial reporter: the new blue catheters cause blood to stagnate in the area just emerging from the puncture site.This is an infectious risk.To limit the risk of infection, the nurses have to change these catheters sometimes daily, causing pain and discomfort for the patients and increasing the risk of infection for the patient.

• Brand Name: CATHENA 22GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11131272
• Report Number: 8041187-2021-00008
• Device Sequence Number: 630409
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• 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): 03/30/2021

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: 12/31/2022
• Device Model Number: 386813
• Device Catalogue Number: 386813
• Device Lot Number: 9361760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1