MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML TB SYRINGE SLIP TIP; PISTON SYRINGE

Catalog Number 309623

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

Patient Problem Hyperglycemia (1905)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown; device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore, device history record review (dhr) or quality notification review (qn) could not be performed.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: since no samples displaying the reported condition were received a potential root cause could not be defined.

Event Description

It was reported that an unspecified number of bd 1ml tb syringe slip tips were involved with the patient experiencing hyperglycemia after device use.There has been no mention of medical intervention applied as a result of the hyperglycemia.The following infodate received for intake: 25-sep-2020; material no.309623; batch no.0135774.Complaint 3 of 3: spouse of consumer reported they received a supply of completely new syringes and consumer's blood sugars have been elevated.Stated one day consumer's blood sugar was 300 and one day it was 280.Stated on (b)(6) 2020, that it was 182, then 383.Stated on (b)(6) 2020, that it was 255.Stated no one showed them how to use the new syringes, and they are not using them anymore.Stated they still have some of the previous syringes, and they are going to use them because consumer's blood sugars are fine with those syringes.Spouse is going to call insurance company to inform that they received different syringes and inquire about obtaining the previous syringes.

• Brand Name: BD 1ML TB SYRINGE SLIP TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10709301
• MDR Text Key: 214160907
• Report Number: 1213809-2020-00728
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: 00382903096237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• 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