MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD; INTERVASCULAR CATHETER

Catalog Number	381934
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
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 has been reported that one 20g x 1.16in (1.1 x 30 mm) insyte autoguard has experienced problems with the sheath bonded to the needle during use.The following has been provided by the initial reporter: cannot pull catheter needle.Cannot pull needle from cannula.
Additional Manufacturer Narrative
H.6.Investigation summary: a physical sample was not available for inspection, but bd was provided with a photo of the defect for evaluation.A review of the device history record was performed for the reported lot, 7342858, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed that the catheter was partially pulled up on the needle.The needle tip appeared to be approximately 1/3 of the way down the catheter tip.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without the physical sample available for investigation a definitive root cause could not be determined from the photo.The manufacturing facility has been notified of this incident and the findings.
Event or Problem Description
It has been reported that one 20g x 1.16in (1.1 x 30 mm) insyte autoguard has experienced problems with the sheath bonded to the needle during use.The following has been provided by the initial reporter: cannot pull catheter needle.Cannot pull needle from cannula.

• Brand Name: 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8777441
• Report Number: 1710034-2019-00742
• Device Sequence Number: 19499546
• Product Code: FOZ
• UDI-Device Identifier: 00382903819348
• UDI-Public: 382903819348
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 11/30/2020
• Device Catalogue Number: 381934
• Device Lot Number: 7342858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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