MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problems Miscarriage (1962); Premature Labor (2465); Underdose (2542)

Event Date 04/08/2020

Event Type  Injury  

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 investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: unable to perform complaint lot history check due to an unknown lot number for difficult/unable to operate & needle clog.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 a dhr review due to an unknown lot number.Investigation conclusion: 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 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.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.

Event Description

It was reported that an unspecified bd pen needle delivered an incomplete dose.The following information was provided by the initial reporter: "tw # (b)(4) captures the fact that the patient gave birth and had subsequent complications in (b)(6).Tw # (b)(4) captures the fact that the patient miscarried in (b)(6).Tw # (b)(4) captures the fact that the patient gave birth prematurely in (b)(6).Other serious criteria: medically significant.One of the fetuses miscarried [abortion spontaneous].Had some bleeding 10 weeks into the pregnancy [vaginal haemorrhage].Patient possibly administered incomplete dose of humalog and basaglar due to issue with kwikpen; np ae [accidental underdose].Mother administered humalog, humulin n and basaglar during pregnancy [maternal exposure during pregnancy].Case description: this spontaneous retrospective maternal case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerns a (b)(6)-year-old female patient of unknown ethnicity.Medical history included pregnancy in (b)(6) during which she developed gestational diabetes.She delivered her first child early.She had a caesarian section due to having a cerebral hemorrhage and during labor with a subsequent coma and was hospitalized in for six weeks post delivery.She had memory issues since the cerebral hemorrhage.Concomitant medications included insulin lispro for unknown indication.The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) via a vial and human insulin isophane suspension (rdna origin) (humulin n) via a vial, at unknown dose and frequency subcutaneously, for the treatment of diabetes, beginning in (b)(6).She also received insulin lispro (rdna origin) (humalog, 100 u/ml) via a pre-filled pen (kwikpen) at unknown dose and frequency and insulin glargine (basaglar 100 u/ml) via a prefilled pen (kwikpen), at 30 units daily, subcutaneously, for the treatment of diabetes, beginning on an unknown date.In (b)(6), while on insulin lispro, human insulin isophane suspension and insulin glargine, she became pregnant.On an unknown date she had some bleeding 10 weeks into the pregnancy.She went to the doctor and found out that she was pregnant with fraternal twins and that one of the fetuses miscarried.She went on to carry the other twin.The due date was reported as (b)(6).On (b)(6), she delivered the twin early by a few weeks.Height and weight of baby was not provided.On an unknown date sometimes, no insulin would come out of the insulin lispro and insulin glargine kwikpen (pc # (b)(4), lot # unknown) (pc # (b)(4), lot # unknown).When she used the twist on, bd needles, things did not always deliver the medication.She was not sure that she always received her full dose when using the kwikpens with the twist on needles.She primed with 01 to 02 units before each injection in the past.On an unknown date, she withdraws the insulin from the pens using syringe and draws up the amount she needs that way.Information regarding any maternal testing was not provided.Information regarding corrective treatment was not provided.The insulin lispro treatment was discontinued.The operator of the kwikpen was patient and her training status was not provided.The kwikpens model duration of use and suspect kwikpens duration of use were not provided.The suspect kwikpens were discarded and their return was not expected.The reporting consumer did not know relatedness between events and insulin lispro or human insulin isophane suspension.The reporting consumer did not provide opinion of relatedness between events and insulin lispro (kwikpen) or insulin glargine.The exposure event was entered for tracking purposes.".

• 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: 9989155
• MDR Text Key: 188651454
• Report Number: 2243072-2020-00646
• 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,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2020
• 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 Outcome(s): Other
• Patient Age: 32 YR