MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA INDIA; INTERVASCULAR CATHETER

Catalog Number 393244

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 venflon pro safety 20ga india experienced needle through needle cover during use.A member of the nursing staff received a needle stick injury while removing the protective shield from the needle.The following information was provided by the initial reporter: vps 20g of the batch (lot no.9109977) having issue in removing needle, during the time of removal needle penerates shield & prick (nsi) happens to the nursing staff.In case of 2nd one of vps20g the needle got stuck.

Manufacturer Narrative

H.6.Investigation summary: two photos were received by our quality team for evaluation.Upon visual inspection of the photos received, the first photo shows the needle safety mechanism was not fully activated and the needle is exposed and not contained within the needle cap; therefore, the failure can be verified.The second photo show the shelf carton label with batch #9109977.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 this incident cannot be determined without the physical sample to perform an investigation.

Event Description

It was reported that 2 venflon pro safety 20ga india experienced needle through needle cover during use.A member of the nursing staff received a needle stick injury while removing the protective shield from the needle.The following information was provided by the initial reporter: vps 20g of the batch (lot no.9109977) having issue in removing needle, during the time of removal needle penerates shield & prick (nsi) happens to the nursing staff.In case of 2nd one of vps20g the needle got stuck.

• Brand Name: VENFLON PRO SAFETY 20GA INDIA
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9213709
• MDR Text Key: 166953374
• Report Number: 8041187-2019-00834
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 393244
• Device Lot Number: 9109977
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other