MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	393229
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code: (b)(4).Fda patient problem code: (b)(4).
Event or Problem Description
It was reported that blood leaked from the bd venflon¿ pro safety peripheral safety iv catheter injection port during use.The following information was provided by the initial reporter: "approximately ten minutes after insertion, and similar time after use for drug administration and saline flush, blood noticed leaking from injection port.Injection port vale noted to have migrated towards capped end of cannula so no longer sealing cannula port.Likely to have occurred at time of flushing with 20 ml bd plastipak syringe because change in resistance recalled at this time but cannula not noted to be malfunctioning.Details of injury (to patient, carer or healthcare professional): minor blood loss during anaesthesia.Additional cannulation required.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) cannula replaced.".
Event or Problem Description
It was reported that blood leaked from the bd venflon¿ pro safety peripheral safety iv catheter injection port during use.The following information was provided by the initial reporter: "approximately ten minutes after insertion, and similar time after use for drug administration and saline flush, blood noticed leaking from injection port.Injection port vale noted to have migrated towards capped end of cannula so no longer sealing cannula port.Likely to have occurred at time of flushing with 20 ml bd plastipak syringe because change in resistance recalled at this time but cannula not noted to be malfunctioning.Details of injury (to patient, carer or healthcare professional): minor blood loss during anaesthesia.Additional cannulation required.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) cannula replaced.".
Additional Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation.The returned photo shows a top web of batch 9337562.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 and the event description provided, the probable root cause could be due to a valve issue.Capa# 1379444 has been initiated to address the issue.

• Brand Name: BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11101951
• Report Number: 8041187-2020-00889
• Device Sequence Number: 876601
• Product Code: FOZ
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 11/30/2022
• Device Catalogue Number: 393229
• Device Lot Number: 9337562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1