MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1ML ALLERGIST TRAY W/ 27GX1/2IN. BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE; ALLERGY SYRINGE AND NEEDLE

Catalog Number 305540

Device Problems Bent (1059); Material Protrusion/Extrusion (2979)

Patient Problems Needle Stick/Puncture (2462); Blood Loss (2597)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample has been returned for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

A customer reported the following information regarding a 1 ml allergist tray with 27 g x 1/2 in.Bd precision glide¿ permanently attached needles: "i pulled the needle from the tray with my right (holding the barrel) my left hand was going to pull the gray cap off as i did i felt a sharp object strike my left mid index finger.Upon inspection i saw blood coming from my finger.Further exam revealed that the needle was protruding clear through the syringe cap, bent and clearly not attached to the hub of the needle.The needle looked like a fishing hook." the customer received lab work ((b)(6) panel) per her his/her facility's needle stick protocol and will have labs drawn every three months for one year.The next lab draw is on (b)(6) 2017.

Manufacturer Narrative

Results: one used sample was returned for evaluation.A visual/microscopic inspection revealed the needle was bent and broken off of the syringe.A hole in the needle shield was also observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6062969.Conclusion: although a visual/microscopic inspection confirmed the customer's indicated failure mode, an absolute root cause for this incident cannot be determined.

• Brand Name: 1ML ALLERGIST TRAY W/ 27GX1/2IN. BD PRECISIONGLIDE¿ 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: 6136121
• MDR Text Key: 61149695
• Report Number: 1920898-2016-00045
• 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,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 305540
• Device Lot Number: 6062969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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