MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE

Model Number 328466

Device Problems Leak/Splash (1354); Failure to Deliver (2338); Defective Device (2588)

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

Event Date 01/29/2021

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 8 syringe 0. 5ml 30ga 1/2in uf 10bag 500cs were damaged during use. The following was reported by the initial reporter: "it was reported that the barrel split down the middle and the needle is missing from the syringe. Also, the needle is bent and the needle is curved at the shaft. Verbatim: consumer reported barrel split down the middle. Needle missing from syringe, hub is intact. Needle bent. Needle curved at the shaft. Issues involve 8 syringes. Lot #: 0252891, catalog #: 328466, date of event: unknown, samples: available - sending mail kit. ".

• Brand Name: SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
• 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: 11381373
• MDR Text Key: 233771100
• Report Number: 1920898-2021-00224
• 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: 04/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 328466
• Device Catalogue Number: 328466
• Device Lot Number: 0252891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial