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

Catalog Number 381823

Device Problem Problem with Sterilization (1596)

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

Event Date 11/25/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7299847.Medical device expiration date: 2020-09-30.Device manufacture date: 2017-10-26.Medical device lot #: 8060626.Medical device expiration date: 2021-02-28.Device manufacture date: 2018-03-01.Medical device lot #: 7282659.Medical device expiration date: 2020-09-30.Device manufacture date: 2017-10-09.Medical device lot #: 7342810.Medical device expiration date: 2020-11-30.Device manufacture date: 2017-12-08.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 bd insyte¿ autoguard¿ shielded iv catheters were found to have poor adherence to their primary packaging, losing sterility.

Manufacturer Narrative

The following field was updated due to corrected information: b.5.Describe event or problem: it was reported that 300 bd insyte¿ autoguard¿ shielded iv catheters were found to have poor adherence to their primary packaging, losing sterility.H.6.Investigation: dhr's were performed on the 4 reported lots and there were qn's relating to the quality of the product related to the defect.There was one qn for lot# 8060626 that was not related to the complaint.The photo submitted for review displayed nine packages with either the top or bottom of the blister pack partially opened.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 moved to an alternate supplier for the top web material.

Event Description

It was reported that 300 bd insyte¿ autoguard¿ shielded iv catheters were found to have poor adherence to their primary packaging, losing sterility.

• 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: 8148451
• MDR Text Key: 130027493
• Report Number: 1710034-2018-00901
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381823
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 11/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other