MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Catalog Number 328440

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Fda notified: the initial reporter also notified the fda via medwatch # mw5091141.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 a misaligned scale was found during use with a bd insulin syringe with the bd ultra-fine¿ needle.The following information was provided by the initial reporter, "hello, i want to bring this to your attention.It's been 5 years that my son has been using the bd syringes and each box had different measurements.In all cases the measurements were different.One is a syringe of 1 unit and the other the same 1 unit shows 1.5 units.I have been fighting with bd about this.It affected my son glucose for 5 years.Those errors can cause hypoglycemia and hyperglycemia which can lead to death causes.".

Manufacturer Narrative

H.6.Investigation: customer returned two (2) loose 31gx8mm bd insulin syringes.Consumer stated syringes were of different measurements and they affected her son's glucose.Both returned syringes were examined, then tested using a 0.3ml syringe plug gauge: it was observed that one of the syringes fell out of specification of the plug gauge.A review of the device history record was completed for batch# 9161989.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A visual evaluation of the syringes using a plug gauge (gauge# 10372) determined the scale is in the correct location for (1) of the syringes.Volumetric testing was performed on those (2) syringes and were in the acceptable limits.These meet the requirements of iso 8537.H3 other text : see h.10.

Event Description

It was reported that a misaligned scale was found during use with a bd insulin syringe with the bd ultra-fine¿ needle.The following information was provided by the initial reporter, "hello, i want to bring this to your attention.It's been (b)(4) years that my son has been using the bd syringes and each box had different measurements.In all cases the measurements were different.One is a syringe of (b)(4) unit and the other the same (b)(4) unit shows (b)(4) units.I have been fighting with bd about this.It affected my son glucose for 5 years.Those errors can cause hypoglycemia and hyperglycemia which can lead to death causes.".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9522090
• MDR Text Key: 189051745
• Report Number: 1920898-2019-01473
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 382908440035
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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: Other
• Device Catalogue Number: 328440
• Device Lot Number: 9161989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR