MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.".
Event or Problem Description
It was reported that a pen ndl 31g 5mm 90 count mail order only had a mix of product type in pack before use.The following was reported by the initial reporter: "it was reported that the consumer received a box of needles with two different lot#.The lot#9165998 is the lot# they should have received.Verbatim: from phone call on 2021-03-11 17:39:19: stated, two different lots in one box 1 pen needle affected.Sample: yes.Catalog: 320882 cl.Pir attached to file and email information is copied and pasted below: email received¿2021-03-08 12:49:5 customer called stating he received 2 different needles with lot 3122271, in the same box of needles that are lot 9165998.The lot 9165998 is the lot he should have received.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/18/2021.H.6.Investigation: customer returned (1) sealed 5mm, 31g pen needle from lot # 3122271.Customer states that they received a box of needles with two different lots and lot # 9165998 is the lot they should have received.Lot number 3122271 was manufactured in 2013 while lot number 9165998 was manufactured in 2019.A mix between these two lot numbers would most likely not occur during the manufacturing process.This issue cannot be confirmed.Pen needle dhr batch 9165998 was reviewed.The batch number was built with pen needle assembly line in nov 2019.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.No quality notification was raised on past 12 months on similar non-conformance.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that a pen ndl 31g 5mm 90 count mail order only had a mix of product type in pack before use.The following was reported by the initial reporter: "it was reported that the consumer received a box of needles with two different lot#.The lot#9165998 is the lot# they should have recieved.Verbatim: from phone call on 2021-03-11 17:39:19: stated, two different lots in one box 1 pen needle affected, sample: yes, catalog: 320882 cl.Pir attached to file and email information is copied and pasted below: email received¿2021-03-08 12:49:5customer called stating he received 2 different needles with lot 3122271, in the same box of needles that are lot 9165998.The lot 9165998 is the lot he should have received.".

• Brand Name: PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11601748
• Report Number: 8041187-2021-00237
• Device Sequence Number: 3599662
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 06/30/2024
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 9165998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1