MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L; INTRAVASCULAR CATHETER

Catalog Number 393226

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers that the involved product may have had.The information for each lot number is as follows: medical device lot #: 0144757, medical device expiration date: 2023-05-31, device manufacture date: 2020-05-23, medical device lot #: 0051116, medical device expiration date: 2023-02-28, device manufacture date: 2020-02-20.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 Description

It was reported that venflon pro safety 18ga 1.3mm od 32mm l leaked.The following information was provided by the initial reporter: "blood leakage after using the injection port (20 minutes after the start of the infusion) the same patient.The catheter was removed.This is the third incident with the same customer within a short period of time (see complaint no.: (b)(4)).Two lot numbers are given because the package could not be clearly classified.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/14/2020.H.6.Investigation: one hundred and fifteen representative samples (twenty-two samples from batch 0051116, twenty-nine samples from batch 0144757, and sixty-four samples from batch 0022905) were received by our quality team for evaluation.One used cannula hub and one bd syringe was also received, but as the reported blood leakage is related to the cannula hub, no further investigation was done on the syringe.Upon visual inspection of the used sample it was observed valve had moved towards the cannula hub luer side.The representative samples were subjected to visual inspection and the valve injection test and on one sample from batch 00229905, it was observed that the valve moved towards the cannula hub luer side.No abnormalities were observed from the other representative samples.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of the leakage is due to the injection valve moving within the cannula hub.The leakage was due to injection valve move within the cannula hub.Capa#1379444 has been initiated to address this issue.

Event Description

It was reported that venflon pro safety 18ga 1.3mm od 32mm l leaked.The following information was provided by the initial reporter: "blood leakage - after using the injection port (20 minutes after the start of the infusion) the same patient-.The catheter was removed.This is the third incident with the same customer within a short period of time (see complaint no.: (b)(4)) two lot numbers are given because the package could not be clearly classified.".

• Brand Name: VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10658873
• MDR Text Key: 212758219
• Report Number: 8041187-2020-00656
• 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: 10/21/2020

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
• Device Operator: Other
• Device Catalogue Number: 393226
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other