MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AG BC GLOBAL WING PNK 20GAX1.16IN; INTRAVASCULAR CATHETER

Catalog Number 382934

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Initial reporter email address: (b)(6).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 insyte ag bc global wing pnk 20gax1.16in had a safety system failure.The following information was provided by the initial reporter: we have again encountered a problem with a catheter ref, the safety system did not work.Follow-up with the client: consequences on the patient: none.The nurse was soiled with blood, the blood flowed back when the needle was retracted.The catheter does not contain anything since the problem occurred at the time of insertion.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/15/2020.H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received three unopened units and one retracted unit with its original packaging.Upon inspection of the used unit's porous plug, it was found that the plug has dried media on the outside along with damage to one side of the plug.Damage can be seen along the right of the plug and the black coloring is buildup from blood that escaped through the plug.This confirmed the defect of leakage beyond the plug.The porous plug is locating at the base of the hub, if the plug is damaged or incomplete it may result in blood being splattered through the base of the device upon needle retraction.The representative units were tested for damage and all units passed per specification.Damage to the vent plug may occur during manufacturing due to improper machine setup.In addition, the vent plugs are a raw material received by a vendor.Upon receipt of the vent plugs, inspections are performed.Although your reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the vent plug vendor.A device history record review showed no non-conformance's associated with this issue during the production of this batch.

Event Description

It was reported that insyte ag bc global wing pnk 20gax1.16in had a safety system failure.The following information was provided by the initial reporter: we have again encountered a problem with a catheter ref, the safety system did not work.Follow-up with the client: consequences on the patient: none the nurse was soiled with blood, the blood flowed back when the needle was retracted.The catheter does not contain anything since the problem occurred at the time of insertion.

Manufacturer Narrative

The following field has been updated due to corrected information: h.6.Imdrf annex a grid: a0504.

Event Description

It was reported that insyte ag bc global wing pnk 20gax1.16in had a safety system failure.The following information was provided by the initial reporter: we have again encountered a problem with a catheter ref, the safety system did not work.Follow-up with the client: consequences on the patient: none the nurse was soiled with blood, the blood flowed back when the needle was retracted.The catheter does not contain anything since the problem occurred at the time of insertion.

• Brand Name: INSYTE AG BC GLOBAL WING PNK 20GAX1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11012427
• MDR Text Key: 222085922
• Report Number: 1710034-2020-00796
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 382934
• Device Lot Number: 0191479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 03/01/2021; 05/03/2021
• Supplement Dates FDA Received: 03/07/2021; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1