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

Catalog Number	47369802
Medical Device Problem Codes	Misconnection (1399); Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
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 23g etw x 7 mm pen needle us experienced difficulty operating or not working/functioning, and an inability to deliver insulin/medication during use.The following information was provided by the initial reporter: dull needle& difficult to push the injection button.The patient's family administered the pen to patient.The patient's family claimed that the needle got half way into the skin, but it didn't get completely, and also he/she administration for patient was finished, but medical representative checked the sample, injection button was not injected completely.So it is presumed that the administration is not complete.The doctor said that there might have been a lump in the administration site.
Additional Manufacturer Narrative
H.6.Investigation summary: customer returned (1) open bd 7mm, 23g pen needle without the tear drop label.Customer states that it is difficult to push the button, it was difficult to insert the needle under the skin and the needle didn't get into the skin, and there might have been a lump in the administration site.The returned pen needle was examined under the microscope and tested for point geometry, lube, and cannula od (specs: outer diameter for 23g: 0.0260¿-0.0265¿).The returned pen needle exhibited crystallized medication in the lumen of the cannula, indicating that the sample was used.The sample also exhibited proper geometry of the cannula point the patient end of the cannula, the od was measured as 0.0264¿, and sufficient lube was observed, all of which fall within specifications.A review of the device history record was completed for batch# 7152649.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: unconfirmed: bd was not 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.Based on the above, no additional investigation and no capa is required at this time h3 other text : see section h.10.
Event or Problem Description
It was reported that the 23g etw x 7mm pen needle us experienced difficulty operating or not working/functioning, and an inability to deliver insulin/medication during use.The following information was provided by the initial reporter: dull needle& difficult to push the injection button the patient's family administered the pen to patient.The patient's family claimed that the needle got half way into the skin, but it didn't get completely, and also he/she administration for patient was finished, but medical representative checked the sample, injection button was not injected completely.So it is presumed that the administration is not complete.The doctor said that there might have been a lump in the administration site.
Additional Manufacturer Narrative
Investigation summary: customer returned photos of a 7mm, 23g pen needle attached to a pen.Customer states that it is difficult to push the button, it was difficult to insert the needle under the skin and the needle didn't get into the skin, and there might have been a lump in the administration site.The photos were examined and did not show the cannula.It is difficult to determine if there are any defects with the cannula solely from the photos without the sample.A review of the device history record was completed for batch# 7152649.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: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as it is difficult to determine if there are any defects with the cannula solely from the photos without the sample.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.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the 23g etw x 7mm pen needle us experienced difficulty operating or not working/functioning, and an inability to deliver insulin/medication during use.The following information was provided by the initial reporter: dull needle& difficult to push the injection button the patient's family administered the pen to patient.The patient's family claimed that the needle got half way into the skin, but it didn't get completely, and also he/she administration for patient was finished, but medical representative checked the sample, injection button was not injected completely.So it is presumed that the administration is not complete.The doctor said that there might have been a lump in the administration site.
Additional Manufacturer Narrative
The date of event has been corrected.The following information has been updated: b.3.Date of event : (b)(6) 2019.
Event or Problem Description
It was reported that the 23g etw x 7mm pen needle us experienced difficulty operating or not working/functioning, and an inability to deliver insulin/medication during use.The following information was provided by the initial reporter: dull needle& difficult to push the injection button the patient's family administered the pen to patient.The patient's family claimed that the needle got half way into the skin, but it didn't get completely, and also he/she administration for patient was finished, but medical representative checked the sample, injection button was not injected completely.So it is presumed that the administration is not complete.The doctor said that there might have been a lump in the administration site.

• Brand Name: 23G ETW X 7MM PEN NEEDLE US
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8940672
• Report Number: 1920898-2019-00879
• Device Sequence Number: 16666068
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2019

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: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 47369802
• Device Lot Number: 7152649
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/13/2019; 08/13/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/18/2019; 09/18/2019; 10/29/2019
• 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