MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD¿ ULTRA-FINE¿ MINI 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	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd¿ ultra-fine¿ mini pen needle was clogged.The following information was provided by the initial reporter: "no insulin flow.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 1 bd¿ ultra-fine¿ mini pen needle was clogged.The following information was provided by the initial reporter: "no insulin flow.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-mar-2022.H6: investigation summary: customer returned a single 5mm, 31 gauge pen needle from lot 1075796.The pen needle was visually inspected prior to testing.The pen needle was found to have a bent needle 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 needle appears to be clogged during use.Based on the damage present, the needle 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.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 the pen needle 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 needle 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.
Event or Problem Description
It was reported that 1 bd¿ ultra-fine¿ mini pen needle was clogged.The following information was provided by the initial reporter: "no insulin flow.".

• Brand Name: BD¿ ULTRA-FINE¿ MINI PEN NEEDLE
• 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: 13625625
• Report Number: 9616656-2022-00249
• Device Sequence Number: 5125435
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 1075796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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