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

Model Number 381834

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 16 bd insyte¿ autoguard¿ shielded iv catheter unit packaging and box had different lot identities listed on them.The following information was provided by the initial reporter: "we received claim from.For discrepancy lot number stated in inner vs outer box.Once do checking.Found discrepancy lot number stated in inner is different with outer box".

Manufacturer Narrative

The customer added an additional lot#.The following fields have been updated: describe event or problem: it was reported that 16 bd insyte¿ autoguard¿ shielded iv catheters each from lots 1214228 and 1234567 had unit packaging issues where their boxes had different lot identities listed on them.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1214228.Medical device expiration date: 31-jul-2024.Device manufacture date: 02-aug-2021.The reported lot# 1234567 was not found for the reported catalog# 381834.

Event Description

It was reported that 16 bd insyte¿ autoguard¿ shielded iv catheters each from lots 1214228 and 1234567 had unit packaging issues where their boxes had different lot identities listed on them.The following information was provided by the initial reporter: "we received claim from.For discrepancy lot number stated in inner vs outer box.Once do checking.Found discrepancy lot number stated in inner is different with outer box".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received five photos of a 20ga x 1.16in.Insyte autoguard.Visual inspection of the provided photos discovered that the boxes of the devices had a different lot number than the label on the bigger box.A device history record was reviewed for the lot number 1234567, but it was an invalid lot number.The original label on the dispenser box contains the correct information and matches the shipper box label, but it appears a template label was placed over the dispenser box label.The report of a discrepancy between the over-label and the original dispenser box label and shipper box label was confirmed, but it could not be determined where or when the over-labeling occurred.A device history record review showed no non-conformances associated with this issue during the production batch 1214228.

Event Description

It was reported that 16 bd insyte¿ autoguard¿ shielded iv catheters each from lots 1214228 and 1234567 had unit packaging issues where their boxes had different lot identities listed on them.The following information was provided by the initial reporter: "we received claim from.For discrepancy lot number stated in inner vs outer box.Once do checking.Found discrepancy lot number stated in inner is different with outer box".

• 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
• 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: 15481185
• MDR Text Key: 300997675
• Report Number: 1710034-2022-00539
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

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: 07/31/2024
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 11/14/2022
• Supplement Dates FDA Received: 09/30/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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