MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD PEN NDL 32G 4MM HP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320555

Device Problems Misconnection (1399); Defective Device (2588)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint history check was performed and this is the 2nd related complaint for difficult/unable to operate not getting insulin & does not attach as intended & the 1st.Related complaint for glucose level on lot # and 9204755.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.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 per the applicable operations and met qc specifications.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that insulin is not fully being delivered causing hyperglycemia due to needle not attaching correctly with a bd pen ndl 32g 4mm hp.The following information was provided by the initial reporter: (1 of 2 complaints).Consumer reported high glucose level due to not getting insulin, stated that the needle does not attach to the pen (will not puncture the rubber barrier) so she does not believe that the insulin is going into the injection site.Consumer does not reuse.

• Brand Name: BD PEN NDL 32G 4MM HP
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10026935
• MDR Text Key: 191682480
• Report Number: 9616656-2020-00390
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320555
• Device Lot Number: 9204755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other