MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTEGRA¿ SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/19/2022

Event Type  Injury  

Event Description

It was reported that the unspecified bd integra¿ syringe needle failed to retract and caused a dirty needle stick.No further information was provided.The following information was provided by the initial reporter: "recently an.Employee was stuck with a dirty needle after it punctured her while trying to engage the safety.I think the issue on the particular set of needles is the pink safety piece is not firmly affixed to the hinge portion of the needle.".

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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.H3 other text : see h10.

Event Description

It was reported that the unspecified bd integra¿ syringe needle failed to retract and caused a dirty needle stick.No further information was provided.The following information was provided by the initial reporter: "recently an.Employee was stuck with a dirty needle after it punctured her while trying to engage the safety.I think the issue on the particular set of needles is the pink safety piece is not firmly affixed to the hinge portion of the needle.".

• Brand Name: UNSPECIFIED BD INTEGRA¿ SYRINGE
• Type of Device: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16148418
• MDR Text Key: 307198420
• Report Number: 2243072-2022-02331
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/01/2023
• 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