MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM); INTRAVASCULAR CATHETER

Model Number	381544
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that 2 bd insyte¿ autoguard¿ winged shielded iv catheter 18ga 1.16in (1.3 x 30 mm) experienced a needle that would not retract.Product defect was noted during use.The following information was provided by the initial reporter: material no.: 381544, batch no.: 9113561.Per email: employee hared with me that a psn (patient safety network) was logged on an insyte catheter that would not retract the needle.While i am only aware of this one psn, there is apparently another incident reported by a different nurse.I believe both of these incidents have occurred at the women's and children's user facility.The material # is 381544 and the lot number is 9113561 both incidents were 18ga.Right now they are monitoring to observe any trends.
Event or Problem Description
It was reported that 2 bd insyte¿ autoguard¿ winged shielded iv catheter 18ga 1.16in (1.3 x 30 mm) experienced a needle that would not retract.Product defect was noted during use.The following information was provided by the initial reporter: material no.: 381544 batch no.: 9113561 per email: employee hared with me that a psn (patient safety network) was logged on an insyte catheter that would not retract the needle.While i am only aware of this one psn, there is apparently another incident reported by a different nurse.I believe both of these incidents have occurred at the women's and children's user facility.The material # is 381544 and the lot number is 9113561 both incidents were 18ga.Right now they are monitoring to observe any trends.
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.Complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9806246
• Report Number: 1710034-2020-00152
• Device Sequence Number: 3419005
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/21/2020

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: 03/31/2022
• Device Model Number: 381544
• Device Catalogue Number: 381544
• Device Lot Number: 9113561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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