MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 329515

Device Problem Leak/Splash (1354)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9079564.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-03-20.Medical device lot #: 9051739.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-02-20.Medical device lot #: 9079564.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-03-20.Medical device lot #: 8319647.Medical device expiration date: 2021-12-31.Device manufacture date: 2018-11-15.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd autoshield¿ duo safety pen needle leaked.This was discovered before use.The following information was provided by the initial reporter: material no: 329515, batch no: 9079564, 9051739.It was reported that the customer is having difficulties with pen needles.Verbatim: we have had multiple episodes of issues while giving insulin with an insulin pen and the duoshield needle that we order.Problem description: we have had multiple episodes of nurses attempting to administer insulin via various insulin pens, using the autoshield duo needle.After attempted administration, the nurse will note that there was a large amount of liquid running down the skin of the patient.Often, the patient will additionally state they were not able to feel the injection.We have not previously had a problem with this needle, however, have had multiple episodes in the past couple of months.We currently have supply that we are using in our hospital.From phone call this named caller called informed issues with her 4 nurses and two patients.This caller is the clinical nurse educator of the facility.She viewed the training video on bd website after seeing the 2 patients that were being injected with the bd auto shield duo pen needles were getting elevated glucose levels and sometimes insulin on surface of the patients skin.Caller viewed the technique of the nurses - 4 in total, and informed proper injection technique.The patients had elevated levels were monitored during this time in the past 2 months of use.Additional information provided via email below: bd autoshield duo safety pen needle.We have had multiple episodes of nurses's reporting the medication was not delivered d/t observation of large amount of liquid running down the patients skin after "administration".

Event Description

It was reported that bd autoshield¿ duo safety pen needle leaked.This was discovered before use.The following information was provided by the initial reporter: material no: 329515 batch no:9079564, 9051739 it was reported that the customer is having difficulties with pen needles verbatim: we have had multiple episodes of issues while giving insulin with an insulin pen and the duoshield needle that we order.Problem description: we have had multiple episodes of nurses attempting to administer insulin via various insulin pens, using the autoshield duo needle.After attempted administration, the nurse will note that there was a large amount of liquid running down the skin of the patient.Often, the patient will additionally state they were not able to feel the injection.We have not previously had a problem with this needle, however, have had multiple episodes in the past couple of months.We currently have supply that we are using in our hospital.From phone call this named caller called informed issues with her 4 nurses and two patients.This caller is the clinical nurse educator of the facility.She viewed the training video on bd website after seeing the 2 patients that were being injected with the bd auto shield duo pen needles were getting elevated glucose levels and sometimes insulin on surface of the patients skin.Caller viewed the technique of the nurses - 4 in total, and informed proper injection technique.The patients had elevated levels were monitored during this time in the past 2 months of use.Additional information provided via email below: 1.Bd autoshield duo safety pen needle 3.We have had multiple episodes of nurses's reporting the medication was not delivered d/t observation of large amount of liquid running down the patients skin after "administration".

Manufacturer Narrative

Investigation: customer returned (10) sealed 5mm, 30g autoshield duo samples from lot # 9079564, (4) sealed 5mm, 30g autoshield duo samples from lot # 9051739, and (1) sealed 5mm, 30g autoshield duo sample from lot # 8319647.Customer states that there was a large amount of liquid running down the skin of the patient and were getting elevated glucose levels.All returned pen needles were tested and all were able to expel properly without any observed defects.A lot history review was carried out on all reported lot numbers 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 root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9192219
• MDR Text Key: 163979774
• Report Number: 9616656-2019-00988
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903295159
• UDI-Public: 00382903295159
• Combination Product (y/n): N
• PMA/PMN Number: K110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 329515
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other