MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; CATHETER

Catalog Number 393224

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: the customer provided lot # 0229500p02.This does not match the catalog number provided.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l hub separated.The following information was provided by the initial reporter: during the insertion of the cvp, after punching the vein, the metallic spindle of the cvp retracted itself.The retraction of the mandrel has carried the cannula with it as if the mandrel were not detached from the cannula.At the time of the spindle removal part of the cannula broke remaining in the forearm of the patient, part that was removed with surgical forceps.

Manufacturer Narrative

Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 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 Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l hub separated.The following information was provided by the initial reporter: during the insertion of the cvp, after punching the vein, the metallic spindle of the cvp retracted itself.The retraction of the mandrel has carried the cannula with it as if the mandrel were not detached from the cannula.At the time of the spindle removal part of the cannula breaked remaining in the forearm of the patient, part that was removed with surgical forceps.

• Brand Name: VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11712675
• MDR Text Key: 264711674
• Report Number: 8041187-2021-00338
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1