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

Catalog Number	381454
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the seal on a bd insyte¿ autoguard¿ shielded iv catheter appears degraded, packets opening spontaneously therefore no longer sterile.No injury or medical intervention.
Additional Manufacturer Narrative
H.6.Investigation summary: device/batch history record review findings: review was performed on the lot number: 5163676.The lot number was packaged on packaging line 9 from june 18, 2015 thru june 19, 2015 and august 29, 2015 thru august 29, 2015.The review of the dhr¿s it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in process inspections included but were not limited to blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process, all the inspections passed per specifications.Qn / sap database review findings: there were no reject activity findings relevant to the defect stated in the complaint description 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 current risk is acceptable.Occurrence and severity rankings have not changed.Observations: received two unused iag 16ga unit in partially opened package from the lot number; 5163676.Visual/microscopic examination: one package was partially opened at the bottom of the blister pack.The seal was not compromised in the other package.The product characteristics require a minimum of 1/8¿ seal transfer.Per observation of the photos provided this characteristic was met.In addition, the bottom web in the photos revealed evidence of adequate transfer (adhesive) from the paper top web at the open seals and partially open seals of the packages (blister packs).The key variables that affect seal strength are: seal transfer/width and paper top web adhesive presence.Both variables were included in the observations conclusions: the defect of package damaged-defective-other as stated in event description was confirmed with the returned units.No anomalies were found and all the process characteristics that directly influence the seal strength were observed to be within specification.The units were acceptable per specification requirements.There was no physical evidence to confirm or to support manufacturing process related issues for the defect.Capa 48637 was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7613400
• Report Number: 1710034-2018-00329
• Device Sequence Number: 1317498
• Product Code: FOZ
• UDI-Device Identifier: 30382903814542
• UDI-Public: 30382903814542
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 381454
• Device Lot Number: 5163676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other