MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVENOUS CATHETER

Catalog Number 381423

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on (date) via medwatch # 5072257 19-sep-2017.Per medwatch report, device is available for evaluation; however, there is no customer contact information listed on the report.

Event Description

It was reported that the female patient was admitted to the emergency room (b)(6) 2017 at 1334.While obtaining a patent iv using the bd insyte¿ autoguard¿ shielded iv catheter the patient stated she felt a pop within the vein.While showering the patient reported a dislodged iv and the catheter was not found.(patient thought the catheter remained in the vein) the nurse notified the physician of the patients concerns.This mdr is reported as a serious injury however, no medical intervention was noted in this report.

Manufacturer Narrative

Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The root cause is indeterminate.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• 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: 6988085
• MDR Text Key: 90589043
• Report Number: 1710034-2017-00280
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: 00382903814237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 381423
• Device Lot Number: 7089529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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): Other