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

Catalog Number 393224

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l plastic broke and there was a needle stick injury after use.The following information was provided by the initial reporter: when making a peripheral access, the needle was removed because it was not in the vein.At that moment the protective cap came out, but the plastic broke off at the front of the needle and i stabbed myself.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l plastic broke and there was a needle stick injury after use.The following information was provided by the initial reporter: when making a peripheral access, the needle was removed because it was not in the vein.At that moment the protective cap came out, but the plastic broke off at the front of the needle and i stabbed myself.

• 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: 12016176
• MDR Text Key: 256705668
• Report Number: 8041187-2021-00499
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention