MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD; CATHETER

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ insyte autoguard needle only partially retracted.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.  it was reported that over the weekend a nurse inserted and iv, pushed the button on the insyte and it did not fully retract, she did not realize this and was stuck.

Event Description

It was reported that unspecified bd¿ insyte autoguard needle only partially retracted.The following information was provided by the initial reporter: material no: unknown batch no: unknown.  it was reported that over the weekend a nurse inserted and iv, pushed the button on the insyte and it did not fully retract, she did not realize this and was stuck.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one partially retracted needle assembly.During the visual/microscopic examination of the unit, it was observed that the barrel was damaged (cracked), which inhibited a complete retraction and left the needle tip exposed.The reported issue was confirmed and determined to be related to the manufacturing process.Although the lot number is unknown, preventative maintenance and visual inspections are performed at regular intervals to mitigate the risk from this type of defect per the quality plan.A device history record review could not be performed as the lot number is unknown.H3 other text : see h10.

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11720882
• MDR Text Key: 256837111
• Report Number: 2243072-2021-01252
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other