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

Catalog Number UNKNOWN

Device Problem Misconnection (1399)

Patient Problems Bruise/Contusion (1754); Inflammation (1932); Neuropathy (1983); Pain (1994); No Code Available (3191)

Event Date 05/22/2019

Event Type  malfunction  

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 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 check due to an unknown lot number for needle pain, bruising, injury, 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.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 the patient experienced bursitis on the arm, micro varicose veins in the legs, diabetic neuropathy, a herniated disc, obesity, knee problems, and leg pain from herniation, all after using the unspecified bd¿ pen needles via the humapen luxura champagne to inject unspecified humulin.Additionally, it was reported that the patient had difficulty pressing the injector button, which would hurt their stomach due to force, therefore mucopolysaccharide polysulfuric acid ester was applied after injections to avoid bruising.The patient reportedly reused needles up to several times due to being afraid to break them, and stored them in a device case at room temperature.The following information was provided by the initial reporter: this spontaneous case, reported by a consumer, who contacted the company to report a product complaint, concerns a female patient of unknown age and ethnicity.The patient received unspecified insulin human (unspecified humulin), unknown dose, frequency, route of administration, indication for use and start date.Since unknown date, unclear if before or after starting insulin human therapy, via humapen luxura champagne, the patient started to experience bursitis on arm, micro varicose veins in legs, diabetic neuropathy, herniated disc, obesity, knee problems and leg pain (due to herniation).It was also reported that patient did not see very well, which was related to the cavernous sinus thrombophlebitis.Information regarding lab tests and corrective treatments was not provided.Furthermore, it was reported that, since unknown date, reported on (b)(6) 2019 as for some months already, the patient started to experienced injury and bruising at the injection site due to a device issue.According to the reporter, the device injection button had become hard to press, so the patient had to push it more and, sometimes, it would end up hurting her belly.It was reported that patient used to apply mucopolysaccharide polysulfuric acid ester after the injections to avoid the bruising.Additional corrective treatment was not provided.Furthermore, it was reported that the patient was afraid to break the needle.She used to use the needle 12 and, since unspecified date, she started to use the needle 8, which was smaller, weaker and leaned more on the skin during application (as reported).The patient reused the needles one, two or even three times and stored them in the device case at room temperature.At the time of initial report, on (b)(6) 2019, it was unknown if the patient was recovered from bruising and injury at the injection site.The outcome from the remaining reported events was not recovered.Insulin human therapy status was unknown.The patient was the operator of the device and her training status was not provided.It was unknown how long the humapen luxura champagne model and the reported device had been used.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8674759
• MDR Text Key: 148595685
• Report Number: 2243072-2019-01119
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• 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