MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM; 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	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the bd ultra-fine¿ original pen needles 29g x 12.7mm broke off in patient abdomen when taking injection.Surgery was required to extract the needle.The following information was provided by the initial reporter: spouse stated patient end broke off in her husband abdomen when taking injection stated, she took her husband to emergency room and xrays were done.Stated, needle was located in her husband abdomen and the emergency room doctor referred them to a surgeon.Stated, surgery was performed and needle was removed the same day as needle break.
Additional Manufacturer Narrative
H6: investigation summary customer returned 49 used and 46 unused 12.7mm, 29 gauge pen needles.The unused pen needles feature teardrop labels show the lot number as 1314154.46 of the used pen needles feature cannulas that are bent at their base.None of the pen needles were found to be broken.The damage found would be the likely result of accidentally applying force across the length of the cannula during use, which is more likely to occur due to the length of 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, embecta was unable to confirm the customer¿s indicated failure of needles breaking during use.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that the bd ultra-fine¿ original pen needles 29g x 12.7mm broke off in patient abdomen when taking injection.Surgery was required to extract the needle.The following information was provided by the initial reporter: spouse stated patient end broke off in her husband abdomen when taking injection stated, she took her husband to emergency room and xrays were done.Stated, needle was located in her husband abdomen and the emergency room doctor referred them to a surgeon.Stated, surgery was performed and needle was removed the same day as needle break.

• Brand Name: BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM
• 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: 15635259
• Report Number: 9616656-2022-01116
• Device Sequence Number: 17591910
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/29/2022

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 Model Number: 328203
• Device Catalogue Number: 328203
• Device Lot Number: 1314154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male