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

Catalog Number 382554

Device Problem Device Packaging Compromised (2916)

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 before use a bd insyte¿ autoguard¿ bc shielded iv catheter was found with package seal integrity 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: the review was performed on the lot number 5121518.The product was manufactured on afa line 9 from may 4, 2015 thru may 5, 2015 and packaged on packaging line 11 from 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.Set-up and in-process samples (included but not limited) 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.Td 2015-49 was in use during the production of the lot number.No significant issues were found during the review of the device history record.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 eight unused iag/bc 16ga unit in partially opened package from the lot number; 5121518.Visual/microscopic examination: three of the packages were partially opened at both end of the blister pack.Three packages were partially opened at the top of the blister pack.Two of the packages had seals that were not compromised.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.Per observation of the photos provided this characteristic was met.In addition, the bottom web in the photos revealed evidence of adequate transfer (adhesive) from the paper top web at the open seals and partially open seals of the packages (blister packs).The key variables that affect seal strength are: seal transfer/width and top web adhesive presence.Both of these variables were looked at during the investigation.This lot number expired in may 2018.Conclusions: the defect package seal integrity poor/questionable, as stated as the reported coded was confirmed with the returned units.Even though some of 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: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7599030
• MDR Text Key: 111450809
• Report Number: 1710034-2018-00307
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• 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: 05/31/2018
• Device Catalogue Number: 382554
• Device Lot Number: 5121518
• 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: 06/13/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other