MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 1/2IN 90 BX 450 MO PISTON SYRINGE

Model Number 328280

Device Problem Defective Device (2588)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that a syringe 0. 3ml 1/2in 90 bx 450 mo was damaged before use. The following was reported by the initial reporter: "it was reported that the plunger cap is damaged and appears to be chewed. Also, the plunger rod is damaged and the thumb press is missing. Verbatim: consumer reported that the plunger cap is damaged, appears to be chewed up. Also reported plunger rod damaged, stated that the thumb press is missing. Lot #: 9259108. Catalog #: 328280. Date of event: unknownsamples: available - sending mail kit".

• Brand Name: SYRINGE 0.3ML 1/2IN 90 BX 450 MO
• Type of Device: PISTON 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 ; 8015296192
• MDR Report Key: 11248295
• MDR Text Key: 243845199
• Report Number: 1920898-2021-00124
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 328280
• Device Catalogue Number: 328280
• Device Lot Number: 9259108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial