MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRA-FINE¿ MINI PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320882
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.
Event or Problem Description
It was reported when using the unspecified bd mini pen needles, the device experienced the inability to prime.The following information was provided by the initial reporter.The customer stated: i received a phone call from a xxxxxxxx, stating that over the past two years she has had issues with the mini pen needles.The issue is when she is priming the pen needle nothing comes out.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d1: medical device brand name bd ultra-fine¿ mini pen needle.D3: medical device manufacturer becton dickinson medical (singapore).D4 udi: (b)(4).D4.Medical device lot #: 2025239.D4.Medical device expiration date: 30jun2024.H4.Device manufacture date: 28jun2019.G1: g1: manufacturing location becton dickinson medical (singapore).G5: pma/510(k)# k213478.D9: device available for eval yes.D9: returned to manufacturer on: 31dec2021.H.6.Investigation summary: samples were received and an investigation was performed.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.Bd was able to duplicate or confirm the indicated issue.Based on trend analysis, no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.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 when using the bd ultra-fine¿ mini pen needle , the device experienced the inability to prime.The following information was provided by the initial reporter.The customer stated: i received a phone call from a (b)(6), stating that over the past two years she has had issues with the mini pen needles.The issue is when she is priming the pen needle nothing comes out.

• Brand Name: BD ULTRA-FINE¿ MINI PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13172117
• Report Number: 2243072-2021-03039
• Device Sequence Number: 14607569
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: (01)10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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,Followup
• Report Date (Section B): 05/16/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 320882
• Device Lot Number: 9165998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2019
• 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: Female