MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA

Catalog Number 324902

Device Problem Failure to Deliver (2338)

Patient Problem Hypoglycemia (1912)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 1.0ml 31ga 6mm u40 10 bag, (b)(6), experienced insufficient cannula length, and was involved with the lay user/patient experiencing hypoglycemia.It has not been specified whether medical intervention, or additional dosage was administered as a result of the hypoglycemia.The following information was provided by the initial reporter: consumer stated, his number's have been really low.Stated, the pharmacy gave him u-40 syringes to use for insulin injections; stated, has not seen doctor for low number; stated, since he stopped using the u-40 syringes, his numbers have been normal again.Stated that he should have received, 31g, 3/10ml, 6mm.Lot: 7072869; catalog: 324902; date of event: unknown.

Event Description

It was reported that the syringe 1.0ml 31ga 6mm u40 10bag india experienced insufficient cannula length and was involved with the lay user/patient experiencing hypoglycemia.It has not been specified whether medical intervention or additional dosage was administered as a result of the hypoglycemia.The following information was provided by the initial reporter: consumer stated, his number's have been really low.Stated, the pharmacy gave him u-40 syringes to use for insulin injections.Stated, has not seen doctor for low number.Stated, since he stopped using the u-40 syringes, his numbers have been normal again.Stated, the he should have received, 31g, 3/10ml, 6mm.Lot: 7072869.Catalog: 324902.Date of event: unknown.

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7072869.All inspections were performed per the applicable operations qc specifications.H3 other text : see h10.

• Brand Name: SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10840935
• MDR Text Key: 216313729
• Report Number: 1920898-2020-01568
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 324902
• Device Lot Number: 7072869
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other