MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO BLU 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	392523
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that iag bc pro blu 22ga x 1.0in leaked.The following information was provided by the initial reporter: it was reported leakage and hole in catheter (catheter defective/ damaged).Verbatim: the iv was inserted into the patient.The nurse reporting the event stated blood was seen dripping through the proximal end of the catheter as soon as the flash entered the catheter.She initially thought this was blood from the patient puncture site.The catheter was advanced and the button depressed to remove the needle.She attached the j-loop and flushed the catheter which immediately leaked.The iv was removed and the patient needed to sustain an additional iv insertion.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received two opened packages, two used catheter adapter assemblies, and one used retracted needle assembly.Upon inspection of the two catheters, it was identified that damage was present just above the nose of the adapter on both units.The defect of catheter defective/ damaged was confirmed.As a result of this damage, leakage would be expected during use.Based on the location and appearance of the damage, the defect most likely occurred during manufacturing.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that iag bc pro blu 22ga x 1.0in leaked.The following information was provided by the initial reporter: it was reported leakage and hole in catheter (catheter defective/ damaged).Verbatim: the iv was inserted into the patient.The nurse reporting the event stated blood was seen dripping through the proximal end of the catheter as soon as the flash entered the catheter.She initially thought this was blood from the patient puncture site.The catheter was advanced and the button depressed to remove the needle.She attached the j-loop and flushed the catheter which immediately leaked.The iv was removed and the patient needed to sustain an additional iv insertion.

• Brand Name: IAG BC PRO BLU 22GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11918090
• Report Number: 1710034-2021-00456
• Device Sequence Number: 804893
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: 00382903925230
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 392523
• Device Lot Number: 9189504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1