MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309644
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd syringe with hypodermic needle precisionglide the needle penetrated through the shield and punctured a worker's finger.The following information was provided by the initial reporter: date of event- (b)(6) 2022.One of our physicians stuck themselves today with one of these syringes.
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary two pictures of a 10ml luer-lock syringe with a 20x1 inch needle attached (p/n 309644) were received and evaluated.One photo shows the entire syringe with the needle attached in a sealed package and the tip of the needle shield is broken, the second photo is a close-up photo of the same syringe showing the damaged needle shield tip.The condition observed is non-conforming per product specification.Potential root cause for the broken needle shield defect is associated with the assembly process.The batch number is unknown, therefore defective rate cannot be identified.Batch number is required to determine if corrective actions are necessary.The batch number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported while using bd syringe with hypodermic needle precisionglide the needle penetrated through the shield and punctured a worker's finger.The following information was provided by the initial reporter: date of event- 18-mar one of our physicians stuck themselves today with one of these syringes.

• Brand Name: BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14110356
• Report Number: 1213809-2022-00187
• Device Sequence Number: 5288938
• Product Code: FMI
• UDI-Device Identifier: 00382903096442
• UDI-Public: 00382903096442
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309644
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown