MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD¿ PEN NDL 31G 5MM 90CT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
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 has been reported that the bd¿ pen ndl 31g 5mm 90ct has been found with a loose outer cover during use.The following has been provided by the initial reporter: it was reported that the outer cover is loose, making it difficult to remove the needle from the pen after injection.That the outer cover is loose, making it difficult to remove the needle from the pen after injection.Verbatim: consumer reported that the outer cover is loose, making it difficult to remove the needle from the pen after injection.Consumer stated that he stuck his finger while trying to remove the needle from the pen and bleeding occurred, no medical attention sought.Lot # 8074601.Product # 320883.Exp 03-31-2023.Incident date: unknown.Occurrence: unknown.
Event or Problem Description
It has been reported that the bd¿ pen ndl 31g 5mm 90ct has been found with a loose outer cover during use.The following has been provided by the initial reporter: it was reported that the outer cover is loose, making it difficult to remove the needle from the pen after injection.That the outer cover is loose, making it difficult to remove the needle from the pen after injection.Verbatim: consumer reported that the outer cover is loose, making it difficult to remove the needle from the pen after injection.Consumer stated that he stuck his finger while trying to remove the needle from the pen and bleeding occurred, no medical attention sought.Lot # 8074601.Product # 320883.Exp 03-31-2023.Incident date unknown.Occurrence unknown.
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned as of (b)(6) 2019 therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.

• Brand Name: BD¿ PEN NDL 31G 5MM 90CT
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9405776
• Report Number: 9616656-2019-01195
• Device Sequence Number: 18979091
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 03/31/2023
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 8074601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other