MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500 CA

Catalog Number 320469

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: customer returned one (1) loose 30gx8mm, 1ml bd insulin syringe without a cannula shield attached.Consumer reported needle bent on leg during her injection, when she was re-shielding her needle, needle came through the cap and poked her thumb.The returned syringe was examined, and it was observed that the cannula was bent.No cannula shield was returned with this syringe, and no evidence of manufacturing defect was observed.Since the syringe was returned after use, and no manufacturing defects were observed, the probable cause of the bent cannula is user error when using the syringe; improper handling of the syringe during injection or re-shielding can cause the cannula to bend.A review of the device history record was completed for batch# 6039940.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula) not confirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (cannula through shield).Root cause description: the possible root cause for this issue (bent cannula) is: user error.No evidence of manufacturing related issues were observed on the returned samples.Since the syringe was returned after use, and no manufacturing defects were observed, the probable cause of the bent cannula is user error when using the syringe; improper handling of the syringe during injection or re-shielding can cause the cannula to bend.The root cause for the cannula through shield issue cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that a bent needle occurred with a syringe 1.0ml 30ga 8mm 10bag 500 ca.The following information was provided by the initial reporter, consumer reported needle bent on leg during her injection, when she was re shielding her need, needle came thru the cap and poked her thumb that's when she saw and realized the needle was bent on her leg.She stated she bled a little, she cleaned the blood with the kleenex.Consumer uses new needle each time of her injection.She has to give injection once a week she does not visually test he needle to see if it is straight, she has no problem with the needle.".

• Brand Name: SYRINGE 1.0ML 30GA 8MM 10BAG 500 CA
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9500020
• MDR Text Key: 182756762
• Report Number: 1920898-2019-01449
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 320469
• Device Lot Number: 6039940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other