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

Catalog Number 381033

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 needle of bd¿ insyte autoguard bc was broken during use.

Manufacturer Narrative

Investigation summary: received one used unit within an undamaged opened package from lot 8087872.The unit consisted on the catheter/adapter assembly and protective needle cover.The remainder of the unit (components) was not returned.The photos reveal evidence to confirm that the unit photographed and unit received demonstrated similarities.Dhr review showed the lot was built and packaged on afa line 11 from 31mar2018 through 04apr2018.All required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.There were no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.A non-related fining was disclosed; during the packaging of this lot at the label print verification of p-01, the label verification form disclosed that the attached dispenser label was missing (ref 381033) print, which ran through p-04.There was a new start up at p-05, which the new label verification form disclosed that the attached dispenser label contained all information, including (ref381033) print and ran through to p-14.Note that this finding is not relevant to the reported defect associated with this pir.Investigation conclusion: received one used unit within an undamaged opened package from lot 8087872.The unit consisted on the catheter/adapter assembly and protective needle cover.The remainder of the unit (components) was not returned.The photos reveal evidence to confirm that the unit photographed and unit received demonstrated similarities root cause description: the defect could have occurred anywhere the adapter came in contact with machinery within zones 1, 2, and 5.This failure mode does not occur often.The last time this defect was seen was 2016.Rationale: the peura (end user risk analysis) was analyzed t to determine level of risk to customer and potential causes of the defect.The analysis showed that due to low occurrence, current risk is acceptable.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.

Event Description

It was reported that needle of bd¿ insyte autoguard bc was broken during use.

• Brand Name: BD¿ INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8204441
• MDR Text Key: 131762425
• Report Number: 1710034-2018-00945
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Report Date: 02/01/2019

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: 03/31/2021
• Device Catalogue Number: 381033
• Device Lot Number: 8087872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other