MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC GLOBAL PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 381034

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that insyte autog bc global pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the customer reported about ink-like dust found on the sheath of insyte autoguard.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-11-17 investigation summary our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one un-retracted unit with packaging.Upon inspection of returned unit, a black foreign matter was observed embedded within the adapter.The reported issue was confirmed.The material was determined to be burnt particulate resin (non-foreign).The black specks were most likely created as part of the molding process in the manufacturing process.Burnt imbedded resin specks result from material build up in the barrel/screw.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that insyte autog bc global pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the customer reported about ink-like dust found on the sheath of insyte autoguard.

• Brand Name: INSYTE AUTOG BC GLOBAL PNK 20GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10892156
• MDR Text Key: 218198921
• Report Number: 1710034-2020-00743
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 381034
• Device Lot Number: 0049777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1