MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA TW 8MM; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd syringe 0.5ml 30ga tw 8mm had the thumb press broken.The following information was provided by the initial reporter: the push rod is broken.

Event Description

It was reported that 1 bd syringe 0.5ml 30ga tw 8mm had the thumb press broken.The following information was provided by the initial reporter : the push rod is broken.

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.One photo of a 0.5ml safetyglide insulin syringe was provided.The consumer reported that the push rod was broken.The photo was examined, and it was observed that the plunger rod was fractured nearest the thumb press.A review of the device history record was completed for batch# 1056195.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause cannot be determined.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 11/1/2021 h.6.Investigation: the consumer reported that the push rod was broken.A bd safetyglide insulin syringe sample from lot# 1056195 was received along with a photo, and the alleged issue was observed.It was observed that the plunger rod was fractured nearest the thumb press.A review of the device history record was completed for batch# 1056195.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.There were no quality notifications or maintenance dispatches during the production of this batch that pertained to this defect.Root cause cannot be determined.H3 other text : see h.10.

Event Description

It was reported that 1 bd syringe 0.5ml 30ga tw 8mm had the thumb press broken.The following information was provided by the initial reporter : the push rod is broken.

• Brand Name: SYRINGE 0.5ML 30GA TW 8MM
• Type of Device: SYRINGE, ANTISTICK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12392507
• MDR Text Key: 268952014
• Report Number: 1920898-2021-00944
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305934
• Device Lot Number: 1056195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/01/2021; 11/03/2021
• Supplement Dates FDA Received: 10/25/2021; 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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