MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 4MM 32GA PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Codes	Misconnection (1399); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0073554.Medical device expiration date: 2025-04-30.Device manufacture date: 2020-03-13.Medical device lot #: 0160124.Medical device expiration date: 2025-07-31.Device manufacture date: 2020-06-08.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 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.A review of past 12 months quality notification was performed, and no quality notification was raised on the reported defects.The complaint is unconfirmed as no photo / samples of the reported batch were received.Therefore, root cause could not be determined.The complaint will be re-opened and re-investigated if the photo / sample is returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported that bd 4mm 32ga pen needles experienced 29 cases of being unable to deliver medication, and 29 cases of not functioning.The following information was provided by the initial reporter: consumer reported finding several that clog during the injection.Consumer reported the non patient end felt hard to place onto the pen.

• Brand Name: BD 4MM 32GA PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12961072
• Report Number: 8041187-2021-01029
• Device Sequence Number: 16608115
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: Lay User/Patient
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: SEE H10
• 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: 11/09/2021
• Initial Report FDA Received Date: 12/08/2021
• 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