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

Catalog Number 382534

Device Problems Retraction Problem (1536); Sticking (1597)

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

Event Date 05/01/2018

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 the retraction feature of the bd insyte¿ autoguard¿ bc shielded iv catheter has had off and on issues of the retraction button sticking during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

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: device returned to manufacture: yes.

Event Description

It was reported that the retraction feature of the bd insyte autoguard bc shielded iv catheter has had off and on issues of the retraction button sticking during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

H.6.Investigation summary: lot 7323650 was provided, yet it is not a lot number for material 382534.Correct lot number 7223650.Device/batch history record review was performed on the lot number: 7223650.The product was built on afa line 11, from august 17, 2017 thru august 21, 2017.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the setup and in-process sampling plans.Setup and in-process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Qn / sap database review findings: there were no reject activity findings relevant to the defect stated in the pir associated with the lot number provided for this incident.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing: received two iag /bc 20ga units from the lot number 7223650.One unit was used and taped to the paper top web (unit label).One was unused and in a sealed package.Visual/microscopic examination: used unit: the needle was not retracted, and the white button was not depressed.Observed there was no mechanical/physical damage to any of the components (spring, needle hub, grips) or evidence of adhesive on the button or hub.Unused unit: removed from sealed unit package for evaluation.Observed there was no mechanical/physical damage to any of the components (spring, needle hub, grips) or evidence of adhesive on the button or hub.Functional test (needle retraction) was performed: performed the hub twist test on both units then depressed the buttons.The retraction was successful, no delayed reaction was observed.Conclusions: the defect needle retraction failure, as stated in the description of the complaint, was not confirmed with the returned units.The returned units did not display any adverse characteristics that would contribute to the reported defect.The defect described in the incident report could not be confirmed or replicated with the returned units.There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.A formal corrective action will not be initiated at this time.A manufacturing related root cause could not be identified.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that the retraction feature of the bd insyte¿ autoguard¿ bc shielded iv catheter has had off and on issues of the retraction button sticking during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7530136
• MDR Text Key: 109012602
• Report Number: 1710034-2018-00231
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: 00382903825349
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

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: 07/31/2020
• Device Catalogue Number: 382534
• Device Lot Number: 7223650
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/03/2018; 05/03/2018
• Supplement Dates FDA Received: 07/19/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other