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

Catalog Number 393224

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was received by our quality team for evaluation. From the photo, a carton label with batch 1176162 was observed. 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. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that small amounts of anesthesia and 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: "leakage from injection-port with the pink cap. Occurrence after patient has been anesthetized they injected and small drips came out from the injection-port. They did think more about that as it was small volumes. Then during the anesthesia, blood flowed from that opening as well. Patient (animal) is unharmed".

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12971969
• MDR Text Key: 285755988
• Report Number: 8041187-2021-01038
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 393224
• Device Lot Number: 1176162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial