MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381034

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Illegible Information (4050)

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

Event Date 01/24/2022

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 that 5 bd insyte¿ autoguard¿ bc pro shielded iv catheters' packaging units were torn, and the black tape used to mend them obstructed the label information.The following information was provided by the initial reporter, translated from (b)(6): "when taking sterilized packages out of the carton, the hcp noticed that some were torn with a black tape affixed.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received three photos which displayed two unit packages from product 22ga bd insyte autoguard blood control iv catheters, reference number 381023, lot number 1160971.In addition, two unit packages with iv devices in the same condition to those shown in the provided photos was received.Through the visual observation of both the photos and units confirm that the black tape at the bottom of the package is splice tape and is resulting in a breach in the seal to the extent that the packages are opened at the sides of the seal, therefore compromising the sterility of the product.The reported issue was confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error in the packaging process.During the packaging process the black tape is used when a new roll of bottom webbing is being installed.Splicing helps align and put the new bottom webbing into the machine.The tape is put on the roll to signal the system to not fill the pockets at the spliced location.It is the operator¿s job to follow the splice through the machine to insure it travels through the machine as desired.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that 5 bd insyte¿ autoguard¿ bc pro shielded iv catheters' packaging units were torn, and the black tape used to mend them obstructed the label information.The following information was provided by the initial reporter, translated from japanese: "when taking sterilized packages out of the carton, the hcp noticed that some were torn with a black tape affixed.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER
• 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: 13481983
• MDR Text Key: 286495923
• Report Number: 1710034-2022-00061
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/01/2022

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 381034
• Device Lot Number: 1160971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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