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

Catalog Number	382554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the bd insyte autoguard bc shielded iv catheter was opened and unsealed prior to use.Reports also stated retraction failure.No serious injuries or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: one sample unit was received for evaluation by our quality engineer team.Upon examination, the unit was observed to be partially open at the top end of the blister pack.The packages were analyzed under uv light, as the adhesive used is uv fluorescent.The uv analysis revealed an adequate amount of top web adhesive.A functionality test resulted in a successful retraction of the needle, with no signs of mechanical or physical damage that could contribute to the reported issue of needle retraction failure.Although the defect of package seal integrity poor was confirmed, since no physical evidence was found to support manufacturing process related issues, a root cause could not be determined.As reported code: needle retraction failure.Package seal integrity poor/questionable.Event description: vase were routinely reviewing stock on shelves for expiry.The peel apart edges were curled back and pkg appear to be spontaneously opening (no longer sterile).Glue appears disintegrated on pkg edges.Vase also review the cannula functionality.Activation of the mechanical button does not appear to retract the stylet into the safety barrel without resistance.The barrel was rotated 360 degrees (as is required to release the tip adhesive) so appears to be faulty.Device/batch history record review: yes.Findings: as this complaint was a mdr; dhr review was performed on the following lot number: 5219921 ¿ the lot number was manufactured on afa line 9 from august 13, 2015 thru august 14, 2015 and packaged on packaging line 11 from august 21, 2015 thru august 21, 2015 per 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.In-process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Set-up and in-process samples included (but not limited to) 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.Visual analysis: observations and testing: received one unused iag/bc 16ga unit in partially opened package from the lot number 5219921.The needle was not retracted and button was not pushed.Visual/microscopic examination of package seal integrity poor/questionable: the package was opened at the bottom of the blister pack.The analysis of top web adhesive: 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 an adequate amount of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Visual/microscopic examination of needle retraction failure: observed there was no mechanical/physical damage to the spring, needle hub, grip, or evidence of adhesive on the button or hub.Observed no signs of bends, cuts, holes, kinks, splits, or wrinkles were found in the catheter tubing or the needle thru catheter.Functional test (needle retraction) was performed: performed the hub twist test then depressed the button.The retraction was successful, no delayed reaction was observed.Investigation samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation for this incident met the manufacturing specification requirements in regards to package seal integrity poor/questionable and needle retraction failure.Investigation conclusion: the defect package seal integrity poor/questionable, as stated in the description of the complaint was confirmed with the returned unit.Even though the package was partially opened, all the processes characteristics that directly influence the seal strength were observed to be within specification.No anomalies were found.The defect of needle retraction failure as stated as the reported coded was not confirmed with the returned units.No physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button.Did the evaluation confirm the customer's experience with the bd product? yes; the customer experience of package seal integrity poor/questionable was confirmed based on the evaluation that was performed on the returned unit.No; the customer experience of needle retraction failure was not confirmed based on the evaluation that was performed on the returned unit.Relationship of device to the reported incident: indeterminate.Comments: package seal integrity: although the unit package was observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.Needle retraction failure: the returned units did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect that was described could not be confirmed or replicated with the returned representative unit.The actual unit described in the incident report was not returned for evaluation.Capa (b)(4) has been opened to investigate the package open seal defects and implement corrective actions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 7089522
• Report Number: 1710034-2017-00438
• Device Sequence Number: 1235167
• Product Code: FOZ
• UDI-Device Identifier: 00382903825547
• UDI-Public: 00382903825547
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110443
• 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): 01/18/2018

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: 07/31/2018
• Device Catalogue Number: 382554
• Device Lot Number: 5219921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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