MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE

Model Number 328512

Device Problems 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 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown. 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 3 syringe 0. 3ml 31ga 8mm 10bag 500 wal were damaged and unable to aspirate during use. The following was reported by the initial reporter: "it was reported that the consumer had difficulty drawing up the medication with three syringes. Also, the plunger bent and was very weak/thin. Verbatim: relion consumer reported difficulty drawing up his medication with 3 syringes. Stated the plunger also seems to bend and is very weak and thin on these syringes. Stated this product is a mess and he will not be using them anymore. Request refund. Lot #0160001cat # 328512 date of event: (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021 for all issues reported samples: yes, sending mail kit".

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL
• 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: 11240770
• MDR Text Key: 242274899
• Report Number: 1920898-2021-00119
• 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: 03/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 0160001
• 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: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial