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

Catalog Number	381854
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E initial reporter facility name: third hospital.Investigation: lot analysis/dhr findings: the lot number was packaged on packaging line 11 from (b)(6) 2015.In process samples passed inspections for blister thickness, bad seal/cut/holes, seal transfer width, package leak test and packaging attributes throughout the packaging process per the control plan.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s1 - o1 level a investigation per cpr ¿ (b)(4).Visual analysis: observations and testing: received 97 unused iag 18ga units from lot number 5300852.Visual/microscopic examination: a 58 units were partially open at one end.A 31 units were partially open at both ends.A 8 units were not open.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 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.Investigation samples(s) meet manufacturing specifications: yes; the returned units provided for evaluation for this incident met the manufacturing specification requirements.Conclusions: the defect of package damaged, as stated in the subject of the pir 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 customer experienced was confirmed based on the evaluation that was performed on the returned units.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, 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: 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 is issue is currently being investigated by capa (b)(4).
Event or Problem Description
It was reported that the packages of the bd insyte¿ autoguard¿ shielded iv catheter were not sealed.There was no report of injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7088856
• Report Number: 1710034-2017-00435
• Device Sequence Number: 13624630
• Product Code: FOZ
• UDI-Device Identifier: 00382903814541
• UDI-Public: 00382903814541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/16/2017

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: 10/31/2018
• Device Catalogue Number: 381854
• Device Lot Number: 5300852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/06/2017
• 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