MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ PEN NEEDLES 31G X 5MM (105 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd ultra-fine¿ pen needles 31g x 5mm (105 count) the cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: user report_29497_22 needles break off after application.
Event or Problem Description
It was reported while using bd ultra-fine¿ pen needles 31g x 5mm (105 count) the cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: user report_29497_22: needles break off after application.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD ULTRA-FINE¿ PEN NEEDLES 31G X 5MM (105 COUNT)
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15891345
• Report Number: 9616656-2022-01290
• Device Sequence Number: 5219143
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: 00382903058914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• 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): 12/02/2022

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: Other
• Device Catalogue Number: 320522
• Device Lot Number: 2046926
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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