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

Catalog Number 381923

Device Problems Bent (1059); Mechanical Problem (1384)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.The device evaluation has not yet been fully completed.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the needle of the bd insyte¿ autoguard¿ was bent, which is not an mdr reportable malfunction.However, during the course of the sample investigation, it was discovered that there was an issue with retraction failure/safety mechanism failure.The needle did not retracted after use.There was no report of injury or further medical intervention.

Manufacturer Narrative

One sample unit was received for evaluation by our quality engineer team.Upon visual/ microscopic examination, the needle was observed partially retracted into the safety barrel, the exposed needle was off center, and damage was present on the grip of the barrel, causing the partial retraction.The needle was repositioned outwardly, the needle was not curved or bent.The damaged grip was determined to be a result of a misalignment in the manufacturing process.The plug probe and load barrel stations have the ability to become misaligned and produce the type of damage observed.Inspections are performed regularly by operators to ensure errors are identified.Device/batch history record review could not be performed as the lot number for this incident is unknown.The defect needle bent; as stated as the reported code was not confirmed with the returned unit.The damage to the grip component prevents a full retraction.The damage observed on the grip was preventing the hub to sit straight; which gave the expose needle the appearance of being bent.Root cause is determined to be related to a manufacturing issue.The plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned sample.When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint a formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD INSYTE¿ AUTOGUARD¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7448540
• MDR Text Key: 106252085
• Report Number: 1710034-2018-00178
• 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: 04/27/2018

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 Catalogue Number: 381923
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other