MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 COUNT); 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	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd nano¿ ultra-fine¿ pen needles 32g x 4mm (90 count) the medication could not be delivered.This occurred 12 times.There was no report of patient impact.The following information was provided by the initial reporter: verbatim- consumer reported when priming, no insulin flows stated, when he tries a second pen needle, it will work 12 pen needles affected lot: 7353668, catalog: 320883, date of event: unknown, samples: yes, product is expired cl, product information: product line: usbd, business unit: diabetes care (dc), product family: pen needle, product component/issue/lot(s): pir- product name: pen needle 32g, lot number(s) and/or serial number(s): (b)(4)- material/catalog number: 320883, quantity involved: 12, contaminated: no, used product to be returned for evaluation: yes, how many units?: 12, is country event occurred unknown: no, country event occurred: united states of america, representative samples?: no, current location of device: end user, replacement or credits for affected devices?: replacement, bd awareness date: (b)(6) 2023, complaint date received: (b)(6) 2023, adverse events: when did the incident occur?: during use death?: no, serious injury: no, erroneous results: no, course treatment changed due to event: no, exposure to blood/bodily fluid: no, medical intervention other than first aid: no, needle/probe stick: no, safety issue: no, other actions taken: no.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-mar-2023.H6: investigation summary: customer returned a total of (12) 32ga 4mm pro loose open pen needles without teardrop label.It was reported that when priming, no insulin flows.All the retuned pen needles visually examined and observed 2 broken npe cannula, one broken npe cannula and 9 without any damages.Clog test was performed on the pen needles without damages and no issues were found.Most likely the customer complaint needle clog occurred due to bent/broken npe cannula.As the samples return were open, root cause cannot be determined.Embecta was able to confirm the issue as bent/broken npe 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 sample received, embecta was able to confirm the customer indicated issue as bent/broken npe.Root cause cannot be determined as the return samples were open.H3 other text : see h10.
Event or Problem Description
It was reported while using bd nano¿ ultra-fine¿ pen needles 32g x 4mm (90 count) the medication could not be delivered.This occurred 12 times.There was no report of patient impact.The following information was provided by the initial reporter: verbatim.Consumer reported when priming, no insulin flows.Stated, when he tries a second pen needle, it will work.12 pen needles affected.Lot: 7353668.Catalog: 320883.Date of event: unknown.Samples: yes.Product is expired cl.Product information.Product line: usbd.Business unit: diabetes care (dc).Product family: pen needle.Product component/issue/lot(s): pir.Product name: pen needle 32g.Lot number(s) and/or serial number(s): (b)(6) material/catalog number: 320883.Quantity involved: 12.Contaminated: no.Used product to be returned for evaluation: yes.How many units?: 12.Is country event occurred unknown: no.Country event occurred: united states of america.Representative samples?: no.Current location of device: end user.Replacement or credits for affected devices?: replacement.Bd awareness date: 2023-03-08.Complaint date received: 2023-03-08.Adverse events.When did the incident occur?: during use death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first aid: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no.

• Brand Name: BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 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 ; 8448235433
• MDR Report Key: 16616548
• Report Number: 9616656-2023-00273
• Device Sequence Number: 4817682
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: (01)10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• 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): 07/13/2023

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: Other
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 7353668
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2017
• 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