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

Catalog Number 381934

Device Problems Peeled/Delaminated (1454); Defective Device (2588); Packaging Problem (3007)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6266503; medical device expiration date: 2019-08-31; device manufacture date: 2016-09-22; medical device lot #: 6168877; medical device expiration date: 2019-05-31; device manufacture date: 2016-06-17.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter package is defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿catheter packages often peel apart".

Manufacturer Narrative

Investigation: during dhr review all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling and quality control plans.There were no indications of the reported defect, as there were no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.Received two 20ga insyte autoguard iv catheter units within partially opened packages: 1st unit was from lot 6266503; all components were present and intact within the blister pack and the package (blister pack) was partially opened at the top and bottom ends.2nd unit was from lot 6168877; all components were present and intact within the blister pack and the package (blister pack) was partially opened at the top end.Visual/microscopic examination (method-n/a): observed that although the unit packages had a partially opened seal at the top and/or bottom ends of the blister pack and the sterility barrier was compromised at the opened end(s); the unit packages (blister packs) demonstrated to have had an adequate seal with no anomalies at time of manufacturing.Note: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met and the analysis revealed adequate top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were included (confirmed) in the investigation.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.Capa#(b)(4) was initiated.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter package is defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿catheter packages often peel apart.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 8464056
• MDR Text Key: 140513863
• Report Number: 1710034-2019-00346
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381934
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other