MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA; INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2022

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 the was unable to be removed due to the rupture of the internal cannula and lead to the blockage of the catheter in the vein.This occurence lead to surgical intervention to remove the catheter from patient.The following information was provided by the initial reporter, translated from italian to english.Ev therapy.Cvp permanence approx.5 hours.Inability to remove the catheter due to rupture of the internal cannula and subsequent blockage of the catheter in the vein.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the mdr 8041187-2022-00577 is a duplicate of 8041187-2022-00563 this supplemental is to cancel mdr 8041187-2022-00577.

Event Description

It was reported that the was unable to be removed due to the rupture of the internal cannula and lead to the blockage of the catheter in the vein.This occurence lead to surgical intervention to remove the catheter from patient.The following information was provided by the initial reporter, translated from italian to english.Ev therapy cvp permanence approx.5 hours inability to remove the catheter due to rupture of the internal cannula and subsequent blockage of the catheter in the vein.

• Brand Name: BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA
• Type of Device: INTRAVASCULAR 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: 15549391
• MDR Text Key: 301237427
• Report Number: 8041187-2022-00577
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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 Catalogue Number: 393222
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 11/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR