MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Model Number 381823

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Fda device problem code: 3007, fda patient problem code: 2645.

Event Description

It was reported that insyte autoguard bl 22ga x 1.0in cut line is not easy to tear.This occurred on 32 occasions.The following information was provided by the initial reporter: the cutting line is not easy to tear.

Manufacturer Narrative

Investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received thirty-four unused units in sealed packages from material number 381923, lot number 0132284 and two photos.A device history record review showed no non-conformances associated with this issue during the production of this batch.During the visual examination it was observed that the perforated slit between the paired packages was present on the top web but did not go through to the bottom web.The paired packages were attempted to be pulled apart, but they would not easily separate confirming the reported defect.Based on the appearance of the defect, the root cause is likely due to low cutting pressure during the perforation step of the manufacturing process.H3 other text : see h.10.

Event Description

It was reported that insyte autoguard bl 22ga x 1.0in cut line is not easy to tear.This occurred on 32 occasions.The following information was provided by the initial reporter: the cutting line is not easy to tear.

• Brand Name: INSYTE AUTOGUARD BL 22GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10978715
• MDR Text Key: 221285358
• Report Number: 1710034-2020-00788
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 0132284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1