MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE

Catalog Number UNKNOWN

Device Problem Positioning Problem (3009)

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

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

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).Device manufacture date: unknown investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr due to unknown lot number.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported that when activating the safety shield on a unspecified bd¿ insulin syringe that was used for a shingles injection, the needle snapped to the side and stuck the finger of the pharmacist.The pharmacist went to the hospital where they were tested for hiv and hpv.

• Brand Name: UNSPECIFIED BD¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• 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 ; 8015652845
• MDR Report Key: 8052403
• MDR Text Key: 126631287
• Report Number: 2243072-2018-01605
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• 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): Other