MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 328506

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Blood Loss (2597)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: n/a.Date received by manufacturer: bd was initially made aware of this complaint on 08/29/2019.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 09/27/2019 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

The original complaint from the customer indicated that there was pain and bleeding associated with the use of a relion® insulin syringe.The following information was provided by the initial reporter: "relion consumer reported: having two issues with the last two boxes purchased: she's experiencing lots of pain every time she takes her injection.She's experiencing bleeding during injection.Consumer has not seen a doctor for the needle pain and bleeding and does not plan to.Does not reuse her syringes." bd does not consider these issues to be mdr reportable malfunctions.However, upon receipt of the patient¿s samples, foreign matter was observed on two of the returned devices.Therefore, bd is reporting this customer complaint as an issue related to foreign matter on the cannula/in the fluid pathway of the device.

Manufacturer Narrative

Investigation: customer returned (20) 1cc, 8mm, 31g relion syringes in open poly bags from lot # 9014606.Customer states that there is pain and bleeding during the injection.All returned syringes were examined and 2 out of 20 samples exhibited material on the cannula.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely polypropylene.All 18 remaining syringes were tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications for these samples.A review of the device history record was completed for batch# 9014606.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200804715] noted that did not pertain to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.(plastic on cannula) unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.(pain and bleeding) visual inspection found plastic fm on the cannula tip and mid section.The ftir spectra analysis performed at flks determined the fm to be polypropylene.The cannulator station assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip.The assembly is transferred via conveyor through a uv oven to cure the adhesive.Unable to determine the root cause of the plastic on the cannula during assembly.

Event Description

The original complaint from the customer indicated that there was pain and bleeding associated with the use of a relion® insulin syringe.The following information was provided by the initial reporter: "relion consumer reported: having two issues with the last two boxes purchased: she's experiencing lots of pain every time she takes her injection.She's experiencing bleeding during injection.Consumer has not seen a doctor for the needle pain and bleeding and does not plan to.Does not reuse her syringes." bd does not consider these issues to be mdr reportable malfunctions.However, upon receipt of the patient¿s samples, foreign matter was observed on two of the returned devices.Therefore, bd is reporting this customer complaint as an issue related to foreign matter on the cannula/in the fluid pathway of the device.

• Brand Name: RELION® INSULIN SYRINGE
• 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 ; 8015652341
• MDR Report Key: 9132098
• MDR Text Key: 167583848
• Report Number: 1920898-2019-01050
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328506
• Device Lot Number: 9014606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female