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

Catalog Number 382544

Device Problems Degraded (1153); Unsealed Device Packaging (1444)

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 before use a bd insyte¿ autoguard¿ bc shielded iv catheter was found with sterile breech as "packet adhesive appears degraded, packets opening spontaneously therefore no longer sterile." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

H.6.Investigation summary: device/batch history record review: lot 7215756 was built on afa line 9 from 8aug17 through 14aug2017 and packaged from packaging line 11 from 15aug17 through 17aug2017.Review of dhr revealed all required challenge samples and testing was conducted per specifications and 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: no qn¿s were initiated during the production of the lot number associated with this account.Visual analysis: observations and testing: received 1 insyte autoguard bc 18ga unit from lot number 7215756 exp.2020-07-31.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.Capa 48637 was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.Other actions taken (if applicable): 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: 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: 7603070
• MDR Text Key: 111741335
• Report Number: 1710034-2018-00325
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 382544
• Device Lot Number: 7215756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other