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

Model Number 328291

Device Problems Device Markings/Labelling Problem (2911); Missing Information (4053)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5292670.Medical device expiration date: na.Device manufacture date: 2015-10-28.Medical device lot #: 5173639.Medical device expiration date: na.Device manufacture date: 2015-08-06.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 3 bd insulin syringe with bd ultra-fine¿ needle boxes from lot 5292670, and 1 box from 5173639 were missing the expiration date on their labels.The following information was provided by the initial reporter: "bd insulin syringe 8mm 31g 3/10 a total of 4 boxes are missing the expiration date".

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 batchs # 5173639 and 5292670 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.The batchs were manufactured before expiration dates were put on packaging.H3 other text : see h10.

Event Description

It was reported that 3 bd insulin syringe with bd ultra-fine¿ needle boxes from lot 5292670, and 1 box from 5173639 were missing the expiration date on their labels.The following information was provided by the initial reporter: "bd insulin syringe 8mm 31g 3/10.A total of 4 boxes are missing the expiration date".

• Brand Name: BD INSULIN SYRINGE WITH 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: 11369584
• MDR Text Key: 251436872
• Report Number: 1920898-2021-00212
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282913
• UDI-Public: 00382903282913
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 328291
• Device Catalogue Number: 328291
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1