MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number UNKNOWN

Device Problem Inadequate or Insufficient Training (1643)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Hypoglycemia (1912); Skin Inflammation/ Irritation (4545)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: 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.Due to the batch being unknown, no dhr review can be completed.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.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that the unspecified bd¿ pen needle was difficult to operate during use.The following information was provided by the initial reporter: my blood sugars were too high up to 340's/ still high/ not controlling her blood sugar [blood glucose increased].I am starting to get a little fat around my belly to use for injection sites i am very skinny [injection site mass].¿ blood sugars would get low [blood glucose decreased].Patient possibly used insulin from the humalog junior kwikpen past it's in use period, ns blood sugar increased [incorrect product administration duration].Patient possibly did not receive correct dose of insulin due to device issue, ns blood glucose increased [incorrect dose administered] patient possibly stored humalog junior kwikpen in too hot of temperatures, ns blood glucose increased [product storage error] medical history was not provided.Concomitant medication included insulin glargine (lantus) for diabetes.The patient received insulin lispro (rdna origin) injection (humalog jr, 100u/ml) via a pre-filled pen (kwikpen), at an unknown dose, units frequency and route of administration for the treatment of an unknown indication beginning on an unknown date.The patient received also received insulin lispro (rdna origin) (humalog 100 u/ml) using a vial, at an unknown dose, units frequency and route of administration for the treatment of an unknown indication beginning on an unknown date.On an unknown date, while on insulin lispro (vial) therapy, she had low blood sugar levels (no values, units or reference ranges provided) as the syringes she used with them could not get a smaller or half unit doses, hence, he switched to kwikpens but still had low blood sugars.On an unknown date, while on insulin lispro (kwikpen) therapy, she had a kwikpen that was not working to control the blood sugar, she had blood sugars high up to 340s (no units or reference ranges provided).She did not know if the insulin went bad due to storing in too hot temperatures or using it past in its in-use period.On an unknown date, while on insulin lispro (kwikpen) therapy, she saw insulin puddle at the sight and did not know if she did not get any insulin or just some (incorrect dose administered).When she did other injections after that with the pen and all the insulin went in, blood sugars were still high (no values, units or reference ranges provided).She stopped using that kwikpen and started a new one and it was working fine.Sometimes not only the needle went into the site but also the plastic hub that held the needle does too which caused the bruises.She used bd brand needles.Outcome of the events and corrective treatment was not provided.Status of insulin lispro (kwikpen) treatment was ongoing and insulin lispro (vial) therapy was discontinued on an unknown date.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12783089
• MDR Text Key: 285074747
• Report Number: 2243072-2021-02692
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 65 YR
• Patient Sex: Female