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

Catalog Number 393224

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: four photos were received by our quality team for evaluation.From the photos, the needle cap is observed to be detached from the tether foil and the cannula is exposed.The tether foil folds on the cannula is correctly formed in a zig-zag fold with no abnormalities.The photos also show the top web of the product.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 photos returned, the tether foil end is not torn.However, it seems that the tether foil end hole were stretched, and the hole on the tether foil had become larger.Investigation conclusion: the team is able to confirm the customer experience based on the photos received.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: the probable root cause for the needle cap detaching from the tether foil end could be due to the user accidentally bending the cannula during product withdrawal, and resulted in the tether hole being stretched.The stretched hole became larger which caused the needle cap to detach from the assembly.However, as the sample was not returned and no further investigation can be completed based on the photos returned, the root cause is not able to be established.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l was damaged.The following information was provided by the initial reporter: cannula came apart when inserting into patients arm; puncture wound.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l was damaged.The following information was provided by the initial reporter: cannula came apart when inserting into patients arm; puncture wound.

Manufacturer Narrative

H6: investigation: four photos were received by our quality team for evaluation.From the photos, the needle cap is observed to be detached from the tether foil and the cannula is exposed.The tether foil folds on the cannula is correctly formed in a zig-zag fold with no abnormalities.The photos also show the top web of the product.The team is able to confirm the confirm the customer experience based on the photos received.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 photos returned, the tether foil end is not torn.However, it seems that the tether foil end hole were stretched, and the hole on the tether foil had become larger.As the sample was not returned and no further investigation can be completed based on the photos returned, the root cause is not able to be established.H3 other text : see h10.

• 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: 11366088
• MDR Text Key: 241965876
• Report Number: 8041187-2021-00119
• 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: 03/23/2021

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
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 393224
• Device Lot Number: 0137730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1