MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 18GA 1.16IN; INTRAVASCULAR CATHETER

Model Number 381844

Device Problem Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported 5 bd insyte¿ autoguard¿ shielded iv catheter 18ga 1.16in had missing label information.The following information was provided by the initial reporter, translated from (b)(6): "5 devices in which in their backside are fixed with adhesive tapes, black and transparent, prevent the validation of information contained within it, poor presentation of the packaging.".

Event Description

It was reported 5 bd insyte¿ autoguard¿ shielded iv catheter 18ga 1.16in had missing label information.The following information was provided by the initial reporter, translated from spanish: "5 devices in which in their backside are fixed with adhesive tapes, black and transparent, prevent the validation of information contained within it, poor presentation of the packaging.".

Manufacturer Narrative

Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed black tape and a transparent tape present on five of the units.The two tapes are located on the outside of the top web.The black tape appears as it has been pulled, rolled, and torn.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error during the packaging process.The black tape is used during the packaging process.To reduce the time required to manually feed a new roll the ensure proper feeding of a new roll into the machine.Additionally splice tape is used to challenge the in-line vision sensors.These units should be detected by the in-line vision system and rejected into totes.It is the operator¿s responsibility to ensure the spliced packages are properly rejected.The missing print observed on the packages is a result of the print being placed on the black splice tape.Transparent tape is visible underneath and beside the black tape.Transparent tape is not used during the unit packaging process.For transparent tape to get onto the top web either operator instructions were not followed, or the transparent tape was on the raw material and splice tape was added by an operator to reject the units.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 18GA 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13056704
• MDR Text Key: 285807500
• Report Number: 1710034-2021-01078
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: 00382903818440
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 381844
• Device Catalogue Number: 381844
• Device Lot Number: 0254237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1