MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56"; INTRAVENOUS CATHETER

Catalog Number 381411

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that the bd insyte autoguard-n straight, 24g x 0.56" needle through catheter.The following information was provided by the initial reporter: when sticking patient for an iv i felt a lot of resistance and a white bulge appeared under patient's skin.I thought maybe the catheter had sheared upon insertion and directly withdrew and found that to be the case (the needle instead of passing through the end exit hole punctured through the side of the catheter making a flap in the catheter that remained attached to the catheter--didn't break off).

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 the bd insyte autoguard-n straight, 24g x 0.56" needle through catheter.The following information was provided by the initial reporter: when sticking patient for an iv i felt a lot of resistance and a white bulge appeared under patient's skin.I thought maybe the catheter had sheared upon insertion and directly withdrew and found that to be the case (the needle instead of passing through the end exit hole punctured through the side of the catheter making a flap in the catheter that remained attached to the catheter--didn't break off).

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-jul-2023.H6: investigation summary: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one unsealed 24ga x 0.56in.Insyte-n autoguard unit from lot number 3045830.Additionally, one photo was provided.Visual inspection discovered that no needle was provided for investigation.Only the catheter, packaging, and needle cover were provided.A leak test was performed where a leak on the catheter tubing was discovered.Microscopic analysis confirmed the cut on the catheter tubing resembled a needle spear through.The reported issue was confirmed.As the needle was not provided for investigation, a root cause could not be determined regarding if this defect occurred during manufacturing or during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56"
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17431212
• MDR Text Key: 320734014
• Report Number: 1710034-2023-00852
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: (01)00382903814114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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 Catalogue Number: 381411
• Device Lot Number: 3045830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1