MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿; SAFETY ENGINEERED HYPODERMIC NEEDLE

Catalog Number 305950

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the syringe plunger broke on a 1 ml allergist tray with 27 g x 1/2 in.Bd safetyglide¿ permanently attached, regular bevel needle and cut the nurse's hand during use.The needle also broke off in the patients arm.No medical intervention was reported.

Manufacturer Narrative

Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Device history record review ¿ a review of the device history record was completed for batch # 7026754.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications, (b)(4) ¿ broken thumb press and (b)(4) ¿ bent plungers.Identified defective components/materials were dispositioned as deemed appropriate, prior to closure of each individual notification listed above.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.

• Brand Name: 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿
• Type of Device: SAFETY ENGINEERED HYPODERMIC 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: 6815912
• MDR Text Key: 83460371
• Report Number: 1920898-2017-00174
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 305950
• Device Lot Number: 7026754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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