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

Catalog Number 381934

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

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.(b)(4).

Event Description

It was reported that 100 packaged bd insyte" autoguard" shielded iv catheters had longer needles than normal.The following information was provided by the initial reporter, translated from (b)(6) to english, "the outer packing changed, the large package was opened and the minimum package was not opened, the appearance of each product was different, the needle was longer than the previous batch of products.".

Manufacturer Narrative

Correction: the investigation found that the photos were comparing different lots of the same product.A review of the bill of material revealed that bd had validated a change in the needle covers which would account for the difference in the length between the two lots.Therefore, this is not mdr reportable.

Event Description

It was reported that 100 packaged bd insyte¿ autoguard¿ shielded iv catheters had longer needles than normal.The following information was provided by the initial reporter, translated from chinese to english: "the outer packing changed, the large package was opened and the minimum package was not opened, the appearance of each product was different, the needle was longer than the previous batch of products".

• 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: 10946866
• MDR Text Key: 219554612
• Report Number: 1710034-2020-00775
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 01/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 381934
• Device Lot Number: 8235973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1