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

Catalog Number	381467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported before use a bd insyte¿ autoguard¿ shielded iv catheter had a sterile breach due to packaging that was slightly opened.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
The product was manufactured on afa line 6 from (b)(6) 2016 thru (b)(6) 2016 and packaged on packaging line 11 from (b)(6) 2016 thru (b)(6) 2016.All required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.(b)(4) were issued for suspect wrinkled seal, but these are not related to this complaint.The defect of wrinkled seal occurs on the long side of the package and has not been linked to open seal complaints.Received 2 iag units from lot number 6308948.Unit packages of returned samples were open, but this is basis of the reported issue.Both of the units received were partially open at both sides.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.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Both of these variables were included in the investigation.Conclusion(s): supplier bd supplier oliver-tolas (ot) 29lp uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to oliver-tolas.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.Due to continuous issues with ot, bd is moving to an alternate supplier for the top web material.(b)(4) was opened to investigate the package seal integrity complaints and implement corrective actions.
Event or Problem Description
It was reported before use a bd insyte autoguard shielded iv catheter had a sterile breach due to packaging that was slightly opened.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7877545
• Report Number: 1710034-2018-00634
• Device Sequence Number: 19459839
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 381467
• Device Lot Number: 6308948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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