MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD OBTURATOR FOR VENFLON¿/SAFELON¿

Catalog Number 394252

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is not marketed in the us.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while removing a bd obturator for venflon⯓afelon⠆rom an iv catheter, the device broke off and remained inside the patient.The patient had surgery to try and retrieve the broken obturator but the device was not found.

Manufacturer Narrative

Results: two unused samples were returned for evaluation.A visual/microscopic analysis revealed that both units were in one piece and there was no mechanical/physical damage (splits or nicks) to the threads rod or cone of the obturator.A review of the device history record revealed no irregularities during the manufacture of the reported lot number 5133626.Conclusion: an absolute root cause for this incident cannot be determined as there was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.A potential cause for this failure is the units may have become jammed on the feeding system.The modification to the ma66, obturator assembly machine vacuum pick-up head, was implemented on 4/2015.The tail clipping issue with the pick-up head was a known potential problem in the past and was addressed with a modification to the pick-up head being the solution.

• Brand Name: BD OBTURATOR FOR VENFLON¿/SAFELON¿
• Type of Device: OBTURATOR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5341699
• MDR Text Key: 34978188
• Report Number: 1710034-2016-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 394252
• Device Lot Number: 5133626
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention