MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY CATHETER; INTRAVENOUS CATHETER

Catalog Number 393222

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

It was reported that the bd venflon¿ pro safety catheter cannula had small holes in it caused by the needle piercing through it during use.The following information was provided by the initial reporter: when vps is inserted into the vein.The cannula has small holes, also not fixed well.

Manufacturer Narrative

Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issues of needle bent; catheter defective / damaged were not confirmed but the failure needle through catheter was observed upon inspection and testing of the samples.From the returned photo, blood was observed in the catheter and cannula hub.This indicates a successful penetration.It would not be possible to penetrate the vein if the product had the needle pierced through catheter.Therefore, the probable root cause for the reported defects could be due to user partially withdrawing the needle from the catheter and reinserting the needle into the catheter.The needle than pierced through the catheter, resulting in the damage.However, as it is not possible to confirm how the product was used, the root cause cannot be confirmed.

Event Description

It was reported that the bd venflon¿ pro safety catheter cannula had small holes in it caused by the needle piercing through it during use.The following information was provided by the initial reporter: when vps is inserted into the vein.The cannula has small holes, also not fixed well.

• Brand Name: BD VENFLON¿ PRO SAFETY CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16165191
• MDR Text Key: 308500655
• Report Number: 8041187-2023-00003
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393222
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1