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	04/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that iag bc pro blu 22ga x 1.0in needle broke off.The following information was provided by the initial reporter: material no:392523, batch no: unknown.It was reported that the needle broke off through the side of the sheath.Verbatim: the nurse was starting an iv on a patient and blood began to come out of the site so she pulled out the needle.She could see that the needle had broken off through the side of the sheath.
Additional Manufacturer Narrative
Investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.
Event or Problem Description
It was reported that iag bc pro blu 22ga x 1.0in needle broke off.The following information was provided by the initial reporter: material no:(b)(4).It was reported that the needle broke off through the side of the sheath.Verbatim: the nurse was starting an iv on a patient and blood began to come out of the site so she pulled out the needle.She could see that the needle had broken off through the side of the sheath.

• 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: 11772770
• Report Number: 1710034-2021-00366
• Device Sequence Number: 11870641
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: 00382903925230
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/19/2021

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 Catalogue Number: 392523
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1