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

Catalog Number 381423

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a different bd product was found in a box for bd insyte¿ autoguard¿ shielded iv catheter(s).There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

No samples were returned in support of this complaint.Two photographs were returned of three samples.The photographs revealed one opened dispenser with the label identifying the product as part #381423.Lot #8057880 and three sealed units (blister packs which were identified by the top web sleeve as part#381423, lot # 8057880.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: manufacturing (packaging) - the root cause was operator error during selection of the print sleeve to print the unit label information.Unit labels are setup/printed by an operator and verified by a cill or quality technician, but the error was not identified during this verification or other in-process inspections of the affected product (pallet 17).Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that a different bd product was found in a box for bd insyte autoguard shielded iv catheter(s).There was no report of exposure, injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7669483
• MDR Text Key: 113642624
• Report Number: 1710034-2018-00391
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 381423
• Device Lot Number: 8057880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other