MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386808
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in experienced a safety mechanism that would not activate.The following information was provided by the initial reporter: on an installation of vvp (peripheral venous route), during the withdrawal, the needle was not secured.Major risk of exposure to blood.The blood stop valve has worked.There were no consequences for either the patient or the staff as we immediately noticed the malfunction and took our precautions.
Event or Problem Description
It was reported that the bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in experienced a safety mechanism that would not activate.The following information was provided by the initial reporter: on an installation of vvp (peripheral venous route), during the withdrawal, the needle was not secured = > major risk of exposure to blood the blood stop valve has worked.There were no consequences for either the patient or the staff as we immediately noticed the malfunction and took our precautions.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-03 h6: investigation summary one sample was received by our quality team for evaluation.The sample was observed with the safety mechanism not activated.No dented mark was observed on the cannula and the tip shield was manually pushed through the cannula and was able to activate properly.No safety activation failure 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.See h10.

• Brand Name: SEE H10
• 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: 11829609
• Report Number: 8041187-2021-00417
• Device Sequence Number: 19910506
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: 00382903868087
• 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): 06/03/2021

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: 05/31/2022
• Device Model Number: 386808
• Device Catalogue Number: 386808
• Device Lot Number: 9165815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1