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

Catalog Number 382544

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

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified: the initial reporter also notified the fda on (b)(6) 2020 via medwatch # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 382544, batch no: 0198337.Bd insyte 20ga angiocath had extra piece of plastic on tip and nurse was unable insert.

Manufacturer Narrative

Investigation summary the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.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 the bd insyte¿ autoguard¿ bc shielded iv catheter experienced foreign matter cotnamination.The following information was provided by the initial reporter: material no: 382544 batch no: 0198337 bd insyte 20ga angiocath had extra piece of plastic on tip and nurse was unable insert.

• Brand Name: BD INSYTE AUTOGUARD BC 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: 11098439
• MDR Text Key: 226067624
• Report Number: 1710034-2020-00842
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: 00382903825448
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 06/30/2023
• Device Catalogue Number: 382544
• Device Lot Number: 0198337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• 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
• Patient Age: 31 YR