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

Catalog Number	381447
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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¿ autoguard¿ shielded iv catheter had needle defects that caused difficulty in use.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd insyte autoguard shielded iv catheter had needle defects that caused difficulty in use.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Dhr: n/a - lot unknown no samples or photos were provided for this incident.Observations and/or testing; was not conducted because units were not provided for this incident for the alleged defect of needle defect-other, as stated in the pir.Indeterminate: no units (samples) or photos were provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.Without a sample for evaluation and testing there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.

• 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: 7956220
• Report Number: 1710034-2018-00701
• Device Sequence Number: 1571764
• Product Code: FOZ
• UDI-Device Identifier: 30382903814474
• UDI-Public: 30382903814474
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (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): 11/21/2018

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 Catalogue Number: 381447
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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