MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 for difficult/unable to operate (wrong technique in product usage process) and hypoglycemia due to unknown lot number.Investigation summary: no samples 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 for difficult/unable to operate (wrong technique in product usage process) and hypoglycemia due to 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 number of an unspecified bd insulin syringe were involved in a serious injury -hypoglycemia.No information indicating whether medical intervention or corrective administration were administered have been provided.The following information was provided by the initial reporter: material no: unknown batch no: unknown.This case was provided by a consumer who reported an adverse event concerning a female patient of an unknown age and origin.Medical history included type ii diabetes.Historical drug included insulin.The patient received insulin via a prefilled pen, 30 units at night, daily, beginning on an unspecified date of (b)(6) 2020.Route of administration was not provided.On starting the insulin glargine treatment, she received a few sample needles and purchased some needles but they were terrible.She could not get the needle to stay on the tip of the pen.So, she started using her bd insulin syringes to draw up insulin from the rubber pen tip of the pen, and took her dose as prescribed.Her blood sugar had been running good but there were a few days her blood sugar got down to 90- 110 (no units provided) which was low for her.She has recovered from a decreased blood glucose level.Information regarding corrective treatment, outcome of the remaining event and status of insulin glargine treatment were not provided.The user of the pen was the patient and her training status was not provided.The pen model duration of use and the suspect pen duration of use were not reported but started on (b)(6) 2020.The action taken with the suspect pen and the return status were not provided.

• Brand Name: UNSPECIFIED BD INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• 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: 10054522
• MDR Text Key: 195366343
• Report Number: 2243072-2020-00771
• Device Sequence Number: 1
• Product Code: FMF
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/07/2020
• 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