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

Catalog Number 393224

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

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 safety mechanism did not fully cover the needle and the nurse received a needle stick injury after use.The following information was provided by the initial reporter: a nurse was instaling venflon pro safety 20 g catheter, but the safety mechanism did not cover the needle end when the needle was pulled put from the cannula.The needle was still pointing out from the safety part.And by accident nurse stuck him/her self and the patient has a disease that spreads through blood.Hcp has exposure to very dangerous disease.There is no assure yet, if the disease is transmitted, but they are following the situation.

Manufacturer Narrative

H.6.Investigation: three representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection and the separation force functional test.All samples passed the testing, and no abnormalities were observed.No abnormalities were observed after activation and all needles were able to be contained within the safety mechanism.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.As no actual samples were received, the root cause of this incident cannot be determined.H3 other text : see h.10.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l safety mechanism did not fully cover the needle and the nurse received a needle stick injury after use.The following information was provided by the initial reporter: a nurse was instaling venflon pro safety 20 g catheter, but the safety mechanism did not cover the needle end when the needle was pulled put from the cannula.The needle was still pointing out from the safety part.And by accident nurse stuck him/her self and the patient has a disease that spreads through blood.Hcp has exposure to very dangerous disease.There is no assure yet, if the disease is transmitted, but they are following the situation.

• 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: 11981020
• MDR Text Key: 264053973
• Report Number: 8041187-2021-00492
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 393224
• Device Lot Number: 0199285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other