MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 23G ETW X 7MM PEN NEEDLE¿ US

Catalog Number	47369802
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Initial reporter phone #: unknown.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 there was a sealing defect with a bd 23g etw x 7mm pen needle¿ us.The following information was provided by the initial reporter: the patient found sealing defect when he/she opened the package.To be specific, the white part of the sealing was peeled and the clear part remained.
Additional Manufacturer Narrative
Investigation summary: customer returned (1) 7mm, 23g pen needle from lot # 7152649.Customer states that the white part of the sealing was peeled and the clear part remained.The returned pen needle was examined and exhibited delamination of the tear drop label.A review of the device history record was completed for batch# (b)(4).All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.As per attached investigation reported completed by manufacturing, "probable root cause for the delamination of the tear drop label is from foreign material on top of the spring pack causing more force to be applied during application or from a worn pivot arm being too loose on the spring pack during application.Capa #(b)(4) was opened (b)(6) 2017 to address delamination issues on the pen needle line.The capa was determined effective on (b)(6) 2018.".
Event or Problem Description
It was reported there was a sealing defect with a bd 23g etw x 7mm pen needle¿ us.The following information was provided by the initial reporter: the patient found sealing defect when he/she opened the package.To be specific, the white part of the sealing was peeled and the clear part remained.

• Brand Name: BD 23G ETW X 7MM PEN NEEDLE¿ US
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8476308
• Report Number: 1920898-2019-00312
• Device Sequence Number: 1471653
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 08/31/2022
• Device Catalogue Number: 47369802
• Device Lot Number: 7152649
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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