MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC BLU 22GA X 1.0IN; INTRAVASCULAR CATHETER

Model Number 382523

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 blu 22ga x 1.0in was damaged.The following information was provided by the initial reporter: material no.: 382523 ,batch no.: 0154027.It was reported that when attempting to insert the iv, the needle punctured the vein but the plastic catheter stopped at the skin, and wouldn't follow the path of the iv needle.When the catheter was removed the end of the plastic catheter was jagged, and a new iv had to be placed.Per email: in attempting to insert the iv, the needle punctured the vein but the plastic catheter stopped at the skin, and wouldn't follow the path of the iv needle.When the catheter was removed the end of the plastic catheter was jagged, and a new iv had to be placed.

Event Description

It was reported that insyte autog bc blu 22ga x 1.0in was damaged.The following information was provided by the initial reporter: material no.: 382523 batch no.: 0154027.It was reported that when attempting to insert the iv, the needle punctured the vein but the plastic catheter stopped at the skin, and wouldn't follow the path of the iv needle.When the catheter was removed the end of the plastic catheter was jagged, and a new iv had to be placed.Per email: in attempting to insert the iv, the needle punctured the vein but the plastic catheter stopped at the skin, and wouldn't follow the path of the iv needle.When the catheter was removed the end of the plastic catheter was jagged, and a new iv had to be placed.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one catheter adapter assembly.During the visual/microscopic examination, it was observed that the catheter tip was uneven and a characteristic v shape was present indicating that the cannula had pierced the catheter wall.The reported defect was confirmed.Based on the location of the defect and since the device had been used, bd could not be determined if the defect originated during manufacturing or use of the device.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: INSYTE AUTOG BC BLU 22GA 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: 11103371
• MDR Text Key: 226064126
• Report Number: 1710034-2020-00850
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 0154027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1