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

Catalog Number 382544

Device Problem Degraded (1153)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the adhesive on the packaging seal of the bd insyte¿ autoguard¿bc shielded iv catheter, appears degraded.Therefore, the product is no longer sterile.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

H.6.Investigation summary: device/batch history record review: the lot number was built on afa line 9 and packaged on packaging line 11 from april 8, 2017 thru april 13, 2017.Per review of the dhr it was concluded that all required challenges, samples, and testing were performed per specifications in accordance with the 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.Qn / sap database review: yes.Reason: dhr was reviewed.Findings: 1 non related qn (b)(4)-damaged luer adapter was initiated and disposition of the product, root cause and corrective action(s) were applied according to the quality control plan.Visual analysis: observations and testing: received 1 insyte autoguard bc 18ga units from lot number 7089532 exp.2020-03-31.Visual/microscopic examination: the package received was partially open at one end.Note: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.In addition the paper top web of the returned units was analyzed under uv light.The adhesive 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 adhesive presence.Both of these variables were included in the investigation.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 unit evaluated for this incident was acceptable per the manufacturing specification requirements of the package.Investigation conclusion: relationship of device to the reported incident: indeterminate comment: 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.

• 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
• MDR Report Key: 7601928
• MDR Text Key: 111665857
• Report Number: 1710034-2018-00299
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: 00382903825448
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 382544
• Device Lot Number: 7089532
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other