MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1ML ALLERGIST TRAY WITH 27G X 1/2" BD SAFETYGLIDE¿ PERMANENTLY ATTACHED NEEDLE; ALLERGY SYRINGE AND NEEDLE

Catalog Number 305950

Device Problems Component Missing (2306); No Fail-Safe Mechanism (2990)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6200985.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 clean needle stick injury occurred with a 1 ml allergist tray with 27 g x 1/2 in.Bd safetyglide¿ permanently attached, regular bevel needle because there was no cap on the needle.There was no report of medical intervention.

• Brand Name: 1ML ALLERGIST TRAY WITH 27G X 1/2" BD SAFETYGLIDE¿ PERMANENTLY ATTACHED NEEDLE
• Type of Device: ALLERGY 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: 6433267
• MDR Text Key: 71202092
• Report Number: 1920898-2017-00040
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 305950
• Device Lot Number: 6200985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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