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

Model Number	328203
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd ultra-fine¿ pen needle was difficult to operate.The following information was provided by the initial reporter : the consumer reported the pen needle does not attach or fit correctly.Date of event : unknown.Samples : available.
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¿ pen needle was difficult to operate.The following information was provided by the initial reporter : the consumer reported the pen needle does not attach or fit correctly.Date of event : unknown; samples : available.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-07.H6: investigation summary customer returned a total of 4 used 12.7mm, 29 gauge pen needles.The teardrop labels were not available for lot verification.The pen needles were visually inspected and all were found to have bent needles on the non-patient side of the hub¿s needle cannula.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.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 was able to confirm the customer¿s indicated failure of the pen needle not attaching as intended.The root cause of the difficulty attaching the pen needles to the insulin pen appears to be inserting the pen needle at an extreme angle.The stresses placed on the non-patient end of the cannula resulted in it bending, causing it to obstruct the insulin pen.H3 other text : see h10.

• Brand Name: BD ULTRA-FINE¿ 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: 13316657
• Report Number: 9616656-2022-00019
• Device Sequence Number: 1548127
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/04/2022

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: 07/31/2026
• Device Model Number: 328203
• Device Catalogue Number: 328203
• Device Lot Number: 1187343
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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