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

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).Medical device expiration date: unknown.Additional initial reporter phone#: (b)(6).Device manufacture date: unknown.(b)(4).Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.  the complaint was deemed as mdr reportable therefore a submission will be performed.  shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.

Event Description

It was reported that unspecified bd¿ insyte autoguard needle was partially retracted and caused the nurse to receive a needlestick injury.This was discovered after use.The following information was provided by the initial reporter: material no: unknown.Batch no: unknown.It was reported that the nurse had started an iv with the needle, pushed the button.The needle was retracted correctly.When he went to pick it up later to dispose of it, it slipped from his grasp, he caught it with the open end, near the needle point hitting his palm.The needle apparently displaced far enough to poke through his glove into his palm.Per customer response: what is the date of the needle stick injury? (b)(6) 2020.Was there serious injury? blood exposure.Was there exposure to blood/bodily fluids? yes.Was there medical intervention? blood exposure policy followed.Were there any other actions taken? quality/risk notified of needle performance.

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10434070
• MDR Text Key: 205142655
• Report Number: 2243072-2020-01290
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention