MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG; PISTON SYRINGE

Model Number 324909

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2020

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.

Event Description

It was reported that a bd piston syringe could not aspirate during use.The following was reported from the initial reporter: "it was reported one syringe didn't have a sharp tip, stated the needle would not penetrate her skin.Verbatim: consumer reported one syringe didn't have a sharp tip.Stated the needle would not penetrate her skin.Stated she also had a difficult time drawing the insulin from the vial.".

Event Description

It was reported that a bd piston syringe could not aspirate during use.The following was reported from the initial reporter: "it was reported one syringe didn't have a sharp tip, stated the needle would not penetrate her skin.Verbatim: consumer reported one syringe didn't have a sharp tip.Stated the needle would not penetrate her skin.Stated she also had a difficult time drawing the insulin from the vial.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-23.Investigation summary customer returned (1) 3/10cc, 6mm, 31g syringe in an open poly bag with the shelf carton from lot # 9308363 and filled with approximately 10 units of a cloudy liquid in the barrel.Customer states that one syringe didn't have a sharp tip and the needle would not penetrate her skin and she also had a difficult time drawing the insulin from the vial.The difficult to draw issue cannot be confirmed as the sample was returned filled with approximately 10 units of a cloudy liquid in the barrel.The sample was also examined under the microscope and exhibited a hooked cannula point.A review of the device history record was completed for batch# 9308363.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (hooked point).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (difficult to draw).Hooked cannula point during use of the product by the customer.

• Brand Name: SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10653488
• MDR Text Key: 212148275
• Report Number: 1920898-2020-01381
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: (01)00382903249091
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 324909
• Device Catalogue Number: 324909
• Device Lot Number: 9308363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other