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

Catalog Number 382557

Device Problems Degraded (1153); Contamination /Decontamination Problem (2895)

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

Event Date 05/22/2018

Event Type  malfunction  

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 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

Investigation summary: device/batch history record review: the review was performed on the lot number: 5121525.A total of (b)(4) units were manufactured on afa line 9 may 8, 2015 to may 10, 2015 and packaged on afa packaging line 11 from may 10, 2015 to may 11, 2015.Review of the dhr¿s revealed 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.No significant issues were found during the review of the device history record.Qn / sap database review findings: no qn¿s were initiated during the production of the lot number associated with this account.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Observations and testing: received (b)(4) insyte autoguard bc 16ga units from lot number: 5121525 exp.2018-05.Visual/microscopic examination: one of the units was partially open at both ends.Three of the units were partially open at one end.Four of the units did not have compromised sealing issues.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.Conclusions: the defect package seal integrity poor/questionable, stated in the description of the complaint, was confirmed with the returned units.Even though the packages were partially opened, all the process characteristics that directly influence the seal were observed to be within specification.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.

• 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: 7588655
• MDR Text Key: 111096747
• Report Number: 1710034-2018-00305
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825578
• UDI-Public: 00382903825578
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 382557
• Device Lot Number: 5121525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other