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

Catalog Number	382547
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: device/batch history record review: review of dhr revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed 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.Visual analysis: received one unused 18ga bd insyte autoguard blood control catheter unit within a partially opened package from lot 5121540.All components were present and intact.Visual/microscopic examination: observed that although the unit package had a partially open seal at the top and bottom of the blister pack, the unit package (blister pack) demonstrated to have had an adequate seal with no anomalies at time of manufacturing.Package leak test; was not conducted as the package seal integrity was breached.Note: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition the paper top web of the returned unit was analyzed under uv light.The glue used to seal the top and bottom webs is uv fluorescent.The analysis revealed adequate top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were included in the investigation.Although the defect was confirmed, the units evaluated for this incident passed the manufacturing specification requirements.Investigation conclusion: 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 (seal transfer and top web glue) were met.The units were acceptable per specification requirements.The failure that the customer experienced was confirmed.It was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed.Root cause description: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.
Event or Problem Description
It was reported that the packages of a bd insyte¿ autoguard¿ bc were opened before use.No injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7132036
• Report Number: 1710034-2017-00473
• Device Sequence Number: 1091460
• Product Code: FOZ
• UDI-Device Identifier: 30382903825470
• UDI-Public: 30382903825470
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 382547
• Device Lot Number: 5121540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/19/2017
• 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