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

Catalog Number 382544

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7027704.Medical device expiration date: 2019-12-31.Device manufacture date: 2017-01-27.Medical device lot #: 6119804.Medical device expiration date: 2019-04-30.Device manufacture date: 2016-04-28.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.Received two unused 18ga bd insyte autoguard blood control catheter unit within a partially opened packages.One from lot 7027704 one from lot 6119804.All components were present and intact.Visual/microscopic examination: lot 702774: observed that although the unit package had a partially open seal at the top of the blister pack; the unit package (blister pack) demonstrated to have had an adequate seal with no anomalies at time of manufacturing.Lot 6119804: 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.The package had a tear of the top web (label) at the top of the package.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 units 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 packages were partially opened at the top and/or bottom; the units (blister packs) received and evaluated for this incident was acceptable per the manufacturing specification requirements of the unit package.Investigation conclusion: confirmation of the defect of package seal integrity poor / questionable, as stated in the pr was conclusive with the units provided for this incident; as the units were received with partially opened packaging (blister packs).Although the packages were received partially opened at the top and/or bottom, all the process characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found and all the process characteristics that directly influence the seal strength (seal transfer and top web glue) were met.Confirmed the units were acceptable per specification requirements.The failure of package seal integrity poor / questionable that the customer experienced was confirmed.It was not necessary to achieve reproduction of the customer¿s experience of package seal integrity poor / questionable, as the defect was confirmed.Root cause description: although the packages were received partially opened; there was no physical evidence to confirm or to support manufacturing process related issues for the defect.In addition, packaging operators are responsible to verify the seal transfer/width and that packages are ¿water leak tested¿ every hour.These attribute inspections are done to verify that the packages are sealed adequately prior to placing them within the dispenser.This is issue is currently being investigated by capa (b)(4).

Event Description

It was reported that the packages of bd insyte¿ autoguard¿ bc shielded iv catheter were not sealed before use.No injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7131901
• MDR Text Key: 95736373
• Report Number: 1710034-2017-00471
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382544
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other