MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 14 G X 1.77 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381867

Device Problem Device Packaging Compromised (2916)

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

Event Date 09/07/2017

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.(b)(4).

Event Description

This complaint is mdr reportable.It was reported that the packaging of the 14 g x 1.77 in.(2.1 mm x 45 mm) bd insyte¿ autoguard¿ shielded iv catheter was opened before use.There was no report of injury or medical intervention.

Manufacturer Narrative

Lot analysis: device/batch history record review: yes.Findings: lot 5308734: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 7, 2015 through nov 28, 2015.Per review of the dhr 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.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Td # (b)(4) (engineering study (b)(4)) was issued to temporarily reduce the allowable range of several sealing parameters in order to investigate the raw material issue related to the compromised seal.Lot 4318680: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 19, 2014 through nov 28, 2014.Per review of the dhr 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.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: (b)(4) version i was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis: observations and testing: received a total of 3 iag 14ga units of which 2 were from lot number 7037934 and 3 units from lot 5308745 and 1 unit from lot 4318680.V all of the units received (3) were partially open at both ends.*note: the product characteristics require a minimum of 1/8¿ seal transfer.A sample size of one unit per lot number was taken and was analyzed under uv light.The adhesive used to seal the top and bottom webs is uv fluorescent.The analysis revealed an adequate of top web adhesive.*the key variables that affect seal strength are: seal transfer/width and paper top web glue.Both of these variables were included in the observations.Test description: method no.: results: visual/microscopic, n/a, see observations and testing.Investigation samples(s) meet manufacturing specifications: yes; although the defect was confirmed, the units evaluated for this incident passed the manufacturing specification requirements.Conclusions: the defect of pkg seal integrity poor/ questionable, as stated in the event description was confirmed with the returned units.Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.Did the evaluation confirm the customer's experience with the bd product? yes; the failure of pkg seal integrity poor/ questionable that the customer experienced was confirmed.Were we able to reproduce the customer's experience with the bd product? no; it was not necessary to achieve reproduction of the customer¿s experience of pkg seal integrity poor/ questionable, as the defect was confirmed.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate.Comment: even though the packages came partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.The 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 issue is currently being investigated by capa (b)(4).Corrective action / capa #: capa (b)(4) has been opened to address this issue.Other actions taken (if applicable): packaging operators are responsible to verify package integrity, including the verification that the packages are adequately sealed.In addition, product quality is evaluated during the manufacturing and packaging process with prescribed attributes inspections.These inspections are performed by operators to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action(s) are applied according to the quality control plan.

• Brand Name: 14 G X 1.77 IN. BD INSYTE¿ AUTOGUARD¿ 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: 6914056
• MDR Text Key: 89816651
• Report Number: 1710034-2017-00270
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K984059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 381867
• Device Lot Number: 5308745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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