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

Model Number	8975
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are multiple bd locations where the reported bd device may have been manufactured.While one of the provided lot #s manufacturing sites was confirmed, the other was unknown and its manufacturing site could not be verified.Bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 manufacturer: (b)(4); medical device lot #: 1195598; medical device expiration date: 2026-07-31; manufacturing location: (b)(4); device manufacture date: 2021-07-14.Medical device manufacturer: (b)(4); medical device lot #: unknown; medical device expiration date: unknown; manufacturing location: (b)(4); 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.
Event or Problem Description
It was reported that bd ultra-fine¿ nano¿ pen needle experienced two cases of being unable to deliver insulin.The following information was provided by the initial reporter: consumer stated some of the pen needles were clogged during flow check.
Event or Problem Description
It was reported that bd ultra-fine¿ nano¿ pen needle experienced two cases of being unable to deliver insulin.The following information was provided by the initial reporter: consumer stated some of the pen needles were clogged during flow check.
Additional Manufacturer Narrative
Investigation summary: customer returned a total of 63 used 4mm, 32 gauge nano pen needles.No teardrop labels were returned for lot identification.30 of the pen needles were visually inspected prior to testing.27 of the pen needles were found to have bent needles on the non-patient side of the hub¿s needle cannula.This damage would prevent testing for clogs since the needle cannot properly attach to the pen.As a result, the pen needles appear to be clogged during use.Based on the damage present, the needles bending may have occurred accidentally while the user was preparing the pen needle for use, potentially if the pen was not properly aligned with the cannula.The remaining samples were attached to a test pen filled with saline.Saline was pushed through the system and out the distal tip of the remaining pen needles.No issues were found with the remaining pen needles.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the samples received, bd found that 27 of 30 pen needles had become bent on the non-patient side.This damage could resemble the needle being clogged as a result of insulin not passing through the needle.The root cause of the needles bending appears to be accidental damage from stresses caused by the user during routine use.This would have also given the impression that the needle was clogged since insulin would be unable to pass through the cannula.H3 other text : see h10.

• Brand Name: BD ULTRA-FINE¿ NANO¿ 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13481950
• Report Number: 2243072-2022-00165
• Device Sequence Number: 5246783
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• 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): 03/30/2022

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: Lay User/Patient
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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