MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Volume Accuracy Problem (1675)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.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 for scale marking defective and glucose level due to unknown lot 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 for scale marking defective and glucose level 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.

Event Description

It was reported that unspecified bd¿ syringe has scale marking issues.This causes alterations in glycemic values and the patient got hypoglycemia and hyperglycemia.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that there are differences in volume in each unit.Verbatim: what you do not understand that it is not just a lot that is wrong.I have hundreds of syringes, where exist differences in volume in each unit.Is a mistake of impression of the machines that manufacture these syringes.That minimum amount that is allowed for you, causes a child of (b)(6) pounds, different effect.Since the amount is altered, glycemic values are also altered.Causing hypoglycemia and hyperglycemia.Use those syringes, where each unit is false.You think you are injecting 1 unit to your son and is not, you are injecting 1.5 unit.Because of an error of impressions of the syringes.Do you think that does not alter your blood sugar? do you think that is not dangerous? i have the medical history of my (b)(6) year-old son, who uses his syringes since he was diagnosed with type 1 diabetes ((b)(6) years old) where in all the consultations i tell the doctor endocrinologist: my son's insulin affects him differently giving him the same amount of insulin.The problem is that there should be no difference.For all the damage caused to my son's health for 6 years i will look for a lawyer.I'm also going to show my son's medical history, along with the doctor's notes, where he says: every time i give him insulin, it affects him differently.At that time i didn't know why.Until i discovered the printing error of their syringes.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: 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: 9713699
• MDR Text Key: 188337447
• Report Number: 2243072-2020-00202
• 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: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/14/2020
• 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