MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD SAFETY-LOK¿ TB SYRINGE W/25 G X 5/8 IN. PERMANENTLY ATTACHED NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305554

Device Problem Break (1069)

Patient Problem Underdose (2542)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.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.A sample is not available for evaluation.

Event Description

It was reported that while using a 1 ml bd safety-lok tuberculin syringe with 25 g x 5/8 in.Permanently attached needle to give a (b)(6) vaccination, the needle broke off of the syringe.The nurse administering the vaccination disposed of the device and was concerned that the patient did not receive the full dose of vaccine.The patient will have lab work drawn on his next visit to determine his titer level.

• Brand Name: 1 ML BD SAFETY-LOK¿ TB SYRINGE W/25 G X 5/8 IN. PERMANENTLY ATTACHED NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5594560
• MDR Text Key: 43223850
• Report Number: 1920898-2016-00012
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2016

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: Nurse
• Device Catalogue Number: 305554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 04/21/2016
• 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