MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 18GA 45MM L INDIA; CATHETER

Catalog Number 393247

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/19/2020

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.(b)(4).

Event Description

It was reported that venflon pro safety 18ga 45mm l india needle protruded through shield and caused a needle stick injury to the nursing staff.The following information was provided by the initial reporter: needle tip of venflon pro safety 18 g protruded from the plastic shield while disposing in sharp container and needle pricked the nursing staff and needle stick injury happened to the user.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/30/2020.H.6.Investigation: one photo and one representative sample were received by our quality team for evaluation.From the returned photo, it was observed that the needle safety mechanism was not fully activated and the needle safety mechanism was not fully activated and the needle is exposed and not contained within the needle cap.The representative sample was subjected to visual inspection and separation force functional test.The sample passed the acceptance criteria and no abnormality was observed.No abnormality was observed after activation, and the needle is 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.The probable root cause of this non-conformance could be due to the damage at cannula hub v-clip latch area.Damage at this area could cause the v-clip to disengage from the cannula hub prematurely prior to the safety mechanism being activated.As no actual sample was returned for investigation, the root cause cannot be confirmed.

Event Description

It was reported that venflon pro safety 18ga 45mm l india needle protruded through shield and caused a needle stick injury to the nursing staff.The following information was provided by the initial reporter: needle tip of venflon pro safety 18 g protruded from the plastic shield while disposing in sharp container and needle pricked the nursing staff and needle stick injury happened to the user.

• Brand Name: VENFLON PRO SAFETY 18GA 45MM L INDIA
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11030179
• MDR Text Key: 222124934
• Report Number: 8041187-2020-00845
• 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: 12/22/2020

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: 03/31/2023
• Device Catalogue Number: 393247
• Device Lot Number: 0081813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other