MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD SHIELDED IV CATHETER; PERIPHERAL VASCULAR CATHETER

Catalog Number 381834

Device Problem Delivered as Unsterile Product (1421)

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."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7268945.Medical device expiration date: 2020-08-31.Device manufacture date: 2017-09-25.Medical device lot #: 7222624.Medical device expiration date: 2020-07-31.Device manufacture date: 2017-08-10.Medical device lot #: 7282722.Medical device expiration date: 2020-09-30.Device manufacture date: 2017-10-09." 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 catheter had sterility breach.

Event Description

It was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.It occurred 15,26 and 8 times with batches 7268945, 7222624 and 7282722 respectively.

Manufacturer Narrative

The following field was updated due to corrected information: describe event or problem: it was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.It occurred 15,26 and 8 times with batches 7268945, 7222624 and 7282722 respectively.Investigation: a dhr was performed for the 3 reported lots and review disclosed no reject activity findings throughout the build of these lots that would impact the outcome of the quality of the product relevant to the defect reported.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.It could have been an issue with supplier material, but can¿t be confirmed.A capa was completed for a low level supplier defect in the top web that would have low pull strength, even though all manufacturing specification were met.

• Brand Name: INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: PERIPHERAL VASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8152116
• MDR Text Key: 130048456
• Report Number: 1710034-2018-00897
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• 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,other,user facility
• 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: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381834
• Device Lot Number: SEE H.6
• Date Manufacturer Received: 11/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other