MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326725

Device Problem Contamination (1120)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter compromised sterility.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: i bought a total of 5x boxes of needles in shopee thailand (bd ultra-fine ii short needle 0.5 ml 100 's 30gx8mm) and i got dirty needles.I have no idea how you can reach out to this seller, but they should stop selling dirty needles because this is a serious matter.I always bought those needles and only these batches, i also ordered from different suppliers/sellers but they look the same, so i guess your company has a problem with it.This is the photo you can see inside it has moist in it.I notice that even i order from other sellee are the same.And i dont know what's inside.It's all contaminated.

Event Description

It was reported while using bd ultra-fine¿ ii short needle insulin syringe foreign matter compromised sterility.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: i bought a total of 5x boxes of needles in shopee thailand (bd ultra-fine ii short needle 0.5 ml 100 's 30gx8mm) and i got dirty needles.I have no idea how you can reach out to this seller, but they should stop selling dirty needles because this is a serious matter.I always bought those needles and only these batches, i also ordered from different suppliers/sellers but they look the same, so i guess your company has a problem with it.This is the photo you can see inside it has moist in it.I notice that even i order from other sellee are the same.And i dont know what's inside.It's all contaminated.

Manufacturer Narrative

H6: investigation summary no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (4) photos of 0.5ccm 30ga 8mm syringe, reporting foreign matter.The photos were visually examined, and no issues were observed.Based on the photos provided, embecta was not able to confirm the reported failure.Due to the batch being unknown, no dhr review can be completed.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16729192
• MDR Text Key: 313227800
• Report Number: 1920898-2023-00219
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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: 326725
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/08/2023
• 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: Initial
• Patient Sequence Number: 1