MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE

Catalog Number UNKNOWN

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905); Underdose (2542)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

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 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.Unable to perform dhr review due to unknown lot number for hyperglycemia & difficult/unable to operate.Investigation conclusion: 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: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

Material no: unknown, batch no: unknown.It was reported that during use of the unspecified bd¿ pen needle the pen needle jammed.The following information was provided by the initial reporter: verbatim: blood sugar over 300/ blood sugars all over ranging from 86-300/ finger test showed high results [blood.Glucose increased].Felt funny like tired or lousy with a headache [headache].Felt funny like tired or lousy [fatigue].Patient did not administered full dose of humulin nph due to kwikpen issues, no ae [accidental underdose].Case description: this spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints, concerned a (b)(6) male patient of unknown origin.The medical history included polymyalgia, eyes getting hazy last checked two years ago and historical drug prednisone used for an unknown indication.Concomitant medications included metformin hydrochloride and glipizide both used for type ii diabetes and prednisone for polymyalgia.The patient received human insulin isophane suspension (rdna origin) injection (humulin nph 100u/ml) via a pre-filled pen (kwikpen), for type ii diabetes, beginning on an unspecified date in (b)(6) 2018.Dose, route of administration and frequency were not provided.On an unspecified date in (b)(6) 2018, while on human insulin isophane suspension therapy, his pen had jammed a total of four times.His blood sugar normally runs 180-220 (reference range and units were not provided) and on the day the pen malfunctioned his blood sugar was over 300 (reference range and units were not provided).The pen was not dispensing properly ((b)(4)/lot number c927172c).On (b)(6) 2019, he did a finger test and the blood sugar results were high.On (b)(6) 2019, he was not sure if the medication was working meaning it made him feel funny meant like tired or lousy with a headache and his blood sugars were all over the place ranging from 86-300, in morning his sugar was 191 (regularly 150s) and when he took it later, his sugar was 99.He ate consistent, healthy meals and eating breakfast ((b)(6) and banana).On an unknown date, while on human insulin isophane suspension therapy, after switching needle sizes, the current pen he was using did not inject the full dose and squirted out when he removed it from his skin and did not return to zero, also it was not smooth ((b)(4)/lot number c927172c).He used bd needles and primed every time with two units.Information regarding corrective treatment for events was not provided.Outcome for blood sugar increased was not resolved, accidental underdose was not provided and outcome for remaining events was resolving since an unknown date.Human insulin isophane suspension therapy dose was increased by 12 units.The operator of the kwikpens was the patient and his training status was not provided.The general kwikpen model duration of use was not provided but started on an unspecified date in (b)(6) 2018 and the suspect kwikpens age was not provided as started on an unknown date.Action taken with the suspect kwikpens was not provided and their return was not expected.The initial reporting consumer did not provide relatedness for accidental underdose with insulin isophane suspension drug and was unsure of the relatedness for remaining events with human insulin isophane suspension drug.The initial reporting consumer related the event of blood glucose increased with first kwikpen and remaining events were not associated with first kwikpen.The initial reporting consumer related the event of accidental underdose to second kwikpen and was unsure of relatedness for remaining events with second kwikpen.Update 27-apr-2019: additional information was received on (b)(6) 2019 from initial reporter consumer.Added two medical histories.Added one concomitant drug.Added four lab data reading for blood glucose.Added human insulin isophane suspension therapy start date, one dosage regimen and updated action taken to dose increased.Added one suspect kwikpen device and pc was processed accordingly.Added three non-serious events of tiredness, headache and accidental underdose and updated description as reported for the event of blood sugar increased, updated its outcome to not recovered and updated as reported drug causality from no to unknown.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: PEN 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8619916
• MDR Text Key: 148443512
• Report Number: 2243072-2019-00956
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR