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

Model Number 328512

Device Problem Material Puncture/Hole (1504)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick (dirty), needle stick (clean) and bending during use on lot # 8197680.A review of risk management (b)(4) indicates that the potential risk of this specific reported incident (syringe, needle stick (dirty), needle stick (clean), bending during use) was captured and addressed.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch # 8197680 all inspections were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that an unspecified number of relion® insulin syringes experienced the needle through the shield after recapping during use, resulting in two dirty needle stick injuries.The device operator did not seek medical attention after the incident.The following information was provided by the initial reporter: consumer called initially asking if relion still manufactured 31g, 8mm, 3/10ml syringes, (328512).Stated, he is unable to find them in his local pharmacy and they are used on his dog.Consumer went on to state: he has stabbed his finger as a result of reshielding after injection.He has stabbed his finger during injection because his dog moves around a lot when trying to administer shot.Stated, needle bends when giving his dog the shot due to pet moving a lot to avoid shot did not seek medical.Lot: unknown.Catalog: 328512.Date of event: unknown.

• 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: 10371255
• MDR Text Key: 201826031
• Report Number: 1920898-2020-01006
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: 00681131311786
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 8197680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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