MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 14GA 1.75IN; INTRAVASCULAR CATHETER

Model Number	381467
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the packaging for the bd insyte¿ autoguard¿ shielded iv catheter 14ga 1.75in did not open properly.The following information was provided by the initial reporter: verbatim: material no: 381467 batch no: 9119988.It was reported that at least four packages ripped while correctly opening them.Event description per attached email states: i received another package wrapper from the or today for 381467 (insyste).They have opened as many as 4 trying to get one to open correctly.When the paper rips it's considered a non-sterile opening because paper dust is created.Lot # 9119988.
Event or Problem Description
It was reported that the packaging for the bd insyte¿ autoguard¿ shielded iv catheter 14ga 1.75in did not open properly.The following information was provided by the initial reporter: verbatim: material no: 381467 batch no: 9119988.It was reported that at least four packages ripped while correctly opening them.Event description per attached email states: i received another package wrapper from the or today for 381467 (insyste).They have opened as many as 4 trying to get one to open correctly.When the paper rips it's considered a non-sterile opening because paper dust is created.Lot # 9119988.
Additional Manufacturer Narrative
H.6.: investigation summary : our quality engineer inspected the sample submitted for evaluation.Bd received one opened package from lot number 9119988, reference number 381467.The package was empty of product.Through the visual/microscopic evaluation, the package was observed to be partially opened and torn at one side.This opened package received could not be tested using the pull force fixture.The remaining packaging was peeled to evaluate if it was stuck or continued to peel or tear.No additional tearing occurred, and the remaining top webbing was removed easily leaving less than 25% of top web attached to the bottom web in the seal area which is within specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 14GA 1.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9745809
• Report Number: 2243072-2020-00265
• Device Sequence Number: 16977126
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 04/30/2022
• Device Model Number: 381467
• Device Catalogue Number: 381467
• Device Lot Number: 9119988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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