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

Model Number	328506
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 relion® insulin syringes experienced hub separation from the device.The following information was provided by the initial reporter: spoke with consumer to confirm pharmacy address.Consumer reported, needle hub separated when removing shield.Stated, shield was not hard to remove 2 syringes affected.Lot: 0013346, catalog: 328506, date of event: unknown.
Event or Problem Description
It was reported that 2 relion® insulin syringes experienced hub separation from the device.The following information was provided by the initial reporter: spoke with consumer to confirm pharmacy address.Consumer reported, needle hub separated when removing shield.Stated, shield was not hard to remove.2 syringes affected.Lot: 0013346.Catalog: 328506.Date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2020-11-18.Investigation summary: customer returned (2) 1cc, 8mm, 31g relion syringes in an open poly bag from lot#: 0013346.Customer states that the needle hub separated when removing shield.Both returned syringes were examined and both exhibited a broken cannula.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end, cracked adhesive, and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the epoxy made this observation more apparent.A review of the device history record was completed for batch# 0013346.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure.Root cause is bending / re-straightening mode of failure done by the customer.

• Brand Name: RELION INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10901716
• Report Number: 1920898-2020-01633
• Device Sequence Number: 19468513
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 0013346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1