MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETERS 20 GAUGE X 1.0"; INTRAVASCULAR CATHETER

Model Number	381233
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default medical device expiration date: unknown.Device manufacture date: unknown.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 bd insyte¿ iv catheters 20 gauge x 1.0" had blood exposure as well as a needle stick.The following information was provided by the initial reporter: "3 weeks ago clinician inserted insyte cannula (non-safety) then put needle inside a bluey and then picked it up getting a needle stick.Clinicians on the ward reported that they had no stock of safety cannulas at the time.".
Event or Problem Description
It was reported that bd insyte¿ iv catheters 20 gauge x 1.0" had blood exposure as well as a needle stick.The following information was provided by the initial reporter: "3 weeks ago clinician inserted insyte cannula (non-safety) then put needle inside a bluey and then picked it up getting a needle stick.Clinicians on the ward reported that they had no stock of safety cannulas at the time.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: BD INSYTE¿ IV CATHETERS 20 GAUGE X 1.0"
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13968317
• Report Number: 8041187-2022-00161
• Device Sequence Number: 20077476
• Product Code: FOZ
• UDI-Device Identifier: 30382903812333
• UDI-Public: 30382903812333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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 Model Number: 381233
• Device Catalogue Number: 381233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown