MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381544
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Material no.381544, batch no.8278868.It was reported that during use of the bd insyte¿ autoguard¿ shielded iv catheter the catheter needle hub was broken.The following information was provided by the initial reporter: needed second iv start.The green hub was broken.The product has been discarded unfortunately.First time occurrence has been brought to managers attention.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
Material no.381544 batch no.8278868.It was reported that during use of the bd insyte¿ autoguard¿ shielded iv catheter the catheter needle hub was broken.The following information was provided by the initial reporter: needed second iv start.The green hub was broken.The product has been discarded unfortunately.First time occurrence has been brought to managers attention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8841419
• Report Number: 1710034-2019-00808
• Device Sequence Number: 13806085
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 381544
• Device Lot Number: 8278868
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other