MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SEE H10; PISTON SYRINGE

Model Number 324912

Device Problem Defective Device (2588)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Medical device brand name: bd veo¿ insulin syringe with bd ultra-fine 6mm needle.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 5 bd veo¿ insulin syringes with bd ultra-fine 6mm needles experienced product damage while still considered operable.The following information was provided by the initial reporter: material no.324912 batch no.Unknown.Bd ins syringe 31g 6mm 1ml 100.Damaged & refused 5.

Event Description

It was reported that 5 bd veo¿ insulin syringes with bd ultra-fine 6mm needles experienced product damage while still considered operable.The following information was provided by the initial reporter: material no.324912 batch no.Unknown.Bd ins syringe 31g 6mm 1ml 100.Damaged & refused 5.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown no dhr review can be completed.H3 other text : see h.10.

• Brand Name: SEE H10
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11406820
• MDR Text Key: 246820837
• Report Number: 1920898-2021-00254
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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 Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1