MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEEDLE

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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.Unable to perform dhr check due to an unknown lot number for needle clog, hyperglycemia & difficult/unable to operate.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that an unspecified bd needle was clogged leading to a missed dose.The following information was provided by the initial reporter: "it was reported that the consumer experienced hyperglycemia, he missed a dose and took a partial dose, and experienced a needle clog.Verbatim: medical histories included dizzy spells and mmphysema.Concomitant medication included metformin used for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections via a prefilled pen (kwikpen), with 15 units in morning and 13 units at night via subcutaneous route for the treatment of type 2 diabetes beginning on (b)(6) 2019.Since starting the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he had a blood sugar reading around 400 (units were unknown) however his normal blood sugar range was between 150-170.On an unknown date, while on insulin lispro therapy, his six devices were not functioning because the devices did not work as nothing came out.He experienced an injection where he felt nothing came out and his diabetes was really high.He primed his devices and did not reused the needles (pc numbers: 4920308/ 4920307 and lot numbers: unknown/c989316p).On 18-nov-2019, while on insulin lispro, his blood sugar was 190 around 10:30 am.On an unknown date, he had two kwikpens that did not work, as pens were jammed.The one pen was half-full and he just tried the second pen on 18-nov-2019.There might be needle issues because when a new needle was placed on each pen then insulin came out (pc number: 4954233 and lot numbers: d074675c).He did not always prime the pens.As of 18-feb-2020, sometimes bd nano needles were defective and the insulin did not came out which happened a few times.Sometimes she got a partial dose due to being out of medication.Information regarding corrective treatment and outcome of all the events were not provided.The insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The caregiver was the operator of kwikpen devices and his training status was not provided.The kwikpen devices general model duration of use and the suspect kwikpen devices duration of use were not provided.The action taken with suspect kwikpen devices was not provided.The initial reporting consumer did not know if the event of diabetes mellitus inadequate control was related and did not report relatedness for the remaining events with insulin lispro protamine suspension 75%/insulin lispro 25% drug.The initial reporting consumer considered the event of missed dose was due to kwikpen issue while did not report any relatedness assessment for remaining events with kwikpen devices.Update 25-nov-2019: additional information was received from initial reporter on 18-nov-2019.Added lab data for blood sugar, therapy start date, one dosage regimen and suspect device for kwikpen as well as one new non-serious event of blood sugar increased.Updated the address details for primary reporter and patient as well as date of birth and age for the patient.Updated narrative with the new information.Update 24-feb-2020: additional information received on 18-feb-2020 from the initial reporter.Added two medical histories and a new non-serious event of incorrect dose administered.Updated the narrative with new information.".

Event Description

It was reported that an unspecified bd needle was clogged leading to a missed dose.The following information was provided by the initial reporter: "it was reported that the consumer experienced hyperglycemia, he missed a dose and took a partial dose, and experienced a needle clog.Verbatim: medical histories included dizzy spells and mmphysema.Concomitant medication included metformin used for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections via a prefilled pen (kwikpen), with 15 units in morning and 13 units at night via subcutaneous route for the treatment of type 2 diabetes beginning on (b)(6) 2019.Since starting the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he had a blood sugar reading around 400 (units were unknown) however his normal blood sugar range was between 150-170.On an unknown date, while on insulin lispro therapy, his six devices were not functioning because the devices did not work as nothing came out.He experienced an injection where he felt nothing came out and his diabetes was really high.He primed his devices and did not reused the needles (pc numbers: (b)(4) and lot numbers: unknown/c989316p).On (b)(6) 2019, while on insulin lispro, his blood sugar was 190 around 10:30 am.On an unknown date, he had two kwikpens that did not work, as pens were jammed.The one pen was half-full and he just tried the second pen on (b)(6) 2019.There might be needle issues because when a new needle was placed on each pen then insulin came out (pc number: (b)(4)and lot numbers: d074675c).He did not always prime the pens.As of 18-feb-2020, sometimes bd nano needles were defective and the insulin did not came out which happened a few times.Sometimes she got a partial dose due to being out of medication.Information regarding corrective treatment and outcome of all the events were not provided.The insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The caregiver was the operator of kwikpen devices and his training status was not provided.The kwikpen devices general model duration of use and the suspect kwikpen devices duration of use were not provided.The action taken with suspect kwikpen devices was not provided.The initial reporting consumer did not know if the event of diabetes mellitus inadequate control was related and did not report relatedness for the remaining events with insulin lispro protamine suspension 75%/insulin lispro 25% drug.The initial reporting consumer considered the event of missed dose was due to kwikpen issue while did not report any relatedness assessment for remaining events with kwikpen devices.Update 25-nov-2019: additional information was received from initial reporter on 18-nov-2019.Added lab data for blood sugar, therapy start date, one dosage regimen and suspect device for kwikpen as well as one new non-serious event of blood sugar increased.Updated the address details for primary reporter and patient as well as date of birth and age for the patient.Updated narrative with the new information.Update 24-feb-2020: additional information received on 18-feb-2020 from the initial reporter.Added two medical histories and a new non-serious event of incorrect dose administered.Updated the narrative with new information.".

Manufacturer Narrative

The following fields have been updated with corrections: h.3 reason code for no evaluation: other; if other, specify: see.H.10.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9850775
• MDR Text Key: 188328611
• Report Number: 2243072-2020-00438
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR