MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PRECISIONGLIDE LUER-LOK SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309644
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd precisionglide luer-lok syringe was cracked.The following information was provided by the initial reporter: a hemodialysis (hd) clinic nurse reported to fresenius customer service that they had multiple cracked casings of luerlok tip precision glide needles, some found before use, some during priming, and some during use that could easily spray fluid.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 309644 and lot number 2186984.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.
Event or Problem Description
It was reported that the bd precisionglide luer-lok syringe was cracked.The following information was provided by the initial reporter: a hemodialysis (hd) clinic nurse reported to fresenius customer service that they had multiple cracked casings of luerlok tip precision glide needles, some found before use, some during priming, and some during use that could easily spray fluid.

• Brand Name: BD PRECISIONGLIDE LUER-LOK SYRINGE
• 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: 15973381
• Report Number: 1213809-2022-01229
• Device Sequence Number: 20261272
• Product Code: FMI
• UDI-Device Identifier: 50382903096447
• UDI-Public: 00382903096442
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/19/2022

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: 2186984
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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