MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD SAFETY-LOK¿ INSULIN SYRINGE WITH 29G X 1/2" BD ULTRA-FINE¿NEEDLE; SYRINGE AND NEEDLE

Catalog Number 329464

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The medical device expiration date is unknown as the lot number is unknown.The device manufacture date is unknown as the lot number is unknown.Device evaluation: result - a sample was not returned for evaluation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusions - as there was no actual sample returned for evaluation, an absolute root cause for this incident cannot be determined.If a sample is returned for evaluation, an investigation will be performed and a supplemental report filed.

Event Description

It was reported that after the patient was given an insulin injection with the suspect device, the user went to pull up the safety sheath and it fell apart in his/her hands.The needle did remain inside the plastic part.

• Brand Name: 1 ML BD SAFETY-LOK¿ INSULIN SYRINGE WITH 29G X 1/2" BD ULTRA-FINE¿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: 6291038
• MDR Text Key: 66482218
• Report Number: 1920898-2017-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941657
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329464
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention