MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 381034

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 09/26/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd iag bc pro global pnk 20ga x 1.16in catheter broke.The following information was provided by the initial reporter: description of the facts: part of the cathlon about 2mm remained in the patient¿s arm when it was removed.The nurse noticed a slight tension, so she pulled slightly on the catheter that broke at the time.Vascular surgeons have been consulted, are of the opinion not to remove the tip of the device if there is no sign of infection or inflammation.Clinical consequences and current status of the patient or person involved: patient encounters gene at arm.There were no particular events concerning his state of health.However, the patient still complains of discomfort where the catheter tip is located.

Event Description

It was reported that bd iag bc pro global pnk 20ga x 1.16in catheter broke.The following information was provided by the initial reporter: description of the facts: part of the cathlon about 2mm remained in the patient¿s arm when it was removed.The nurse noticed a slight tension, so she pulled slightly on the catheter that broke at the time.Vascular surgeons have been consulted, are of the opinion not to remove the tip of the device if there is no sign of infection or inflammation.Clinical consequences and current status of the patient or person involved: patient encounters gene at arm.There were no particular events concerning his state of health.However, the patient still complains of discomfort where the catheter tip is located.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.The complaint could not be confirmed and the root cause is undetermined.Dhr could not be performed due to unknown batch number.H3 other text : see h.10.

• Brand Name: BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12738333
• MDR Text Key: 280109495
• Report Number: 1710034-2021-00936
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• 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: 11/17/2021

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: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/06/2021
• 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