MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; TUBERCULIN SYRINGE AND NEEDLE

Catalog Number 309626

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911); Application Program Problem: Medication Error (3198)

Patient Problem Overdose (1988)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The customer indicated that the incident occurred some time in (b)(6) 2017.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that a nurse gave a patient 50 units of insulin instead of 5 units with a 1 ml bd¿ tuberculin syringe with 25 g x 5/8 in.Bd precisionglide¿ detachable needle because he/she misread the syringe markings.The overdose was noticed approximately one minute after insulin administration.The patient received two d50 boluses and his/her blood glucose levels were monitored (unknown frequency).The overdose did not result in a serious injury or patient death.

• Brand Name: 1ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: TUBERCULIN SYRINGE AND NEEDLE
• 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 ; 8015652845
• MDR Report Key: 6390358
• MDR Text Key: 69482619
• Report Number: 1213809-2017-00017
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 309626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• 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): Required Intervention