MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the bd ultra-fine¿ original pen needles 29g x 12.7mm (100 count), an unspecified amount of needles broke off.The needle broke of in patient.Patient went to the dr.To have it removed.The following information was provided by the initial reporter: consumer reported that the needles break off in the injection site.Consumer stated that he goes to the doctor to have them removed, stated that the issue has occurred more than once.
Additional Manufacturer Narrative
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 while using the bd ultra-fine¿ original pen needles 29g x 12.7mm (100 count), an unspecified amount of needles broke off.The needle broke of in patient.Patient went to the dr.To have it removed.The following information was provided by the initial reporter: consumer reported that the needles break off in the injection site.Consumer stated that he goes to the doctor to have them removed, stated that the issue has occurred more than once.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 31-may-2022.H6: investigation summary: customer returned (19) used bd pen needles without tear drop labels, outer covers, or inner shields attached.The customer reported that the needles break off in the injection site, and the needles bend at the patient end during injection.The returned samples were examined, and it was observed that all 19 pen needles featured a broken patient end (pe) cannula.Microscopic examination of the samples revealed characteristics such as residual bends on the hub-end of the fractured cannula, and ovality (deformation from the normally circular cross section) ¿ removal of the epoxy made this evident.When viewed together these are all indicators of bending/re-straightening mode of failure.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.Embecta was able to duplicate or confirm the customer¿s indicated failure (pe cannula broken) the root cause for this issue is user related.The pe cannula was broken by the user after handling the pen needles.H3 other text : see h10.
Event or Problem Description
It was reported that while using the bd ultra-fine¿ original pen needles 29g x 12.7mm (100 count), an unspecified amount of needles broke off.The needle broke of in patient.Patient went to the dr.To have it removed.The following information was provided by the initial reporter: consumer reported that the needles break off in the injection site.Consumer stated that he goes to the doctor to have them removed, stated that the issue has occurred more than once.

• Brand Name: BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT)
• 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: 14187400
• Report Number: 9616656-2022-00449
• Device Sequence Number: 4297745
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2025
• Device Model Number: 328203
• Device Catalogue Number: 328203
• Device Lot Number: 0112362
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 06/02/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/10/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown