MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number	328519
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion plunger rod was difficult to move.This was discovered during use.The following information was provided by the initial reporter: material no: 328519 batch no: 9350454.It was reported that the needles will not penetrate the insulin vial of injection site.Consumer is also having to press hard on the plunger and is bruising.Event description per snow verbatim states: relion consumer reported, some of the needles will not penetrate the insulin vial or his injection site.Stated, he is getting bruising as a result of having to push really hard on the syringe when taking injection.Stated, does not re-use and he rotates different injection sites.Stated, has not seen a doctor.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/1/2020.H.6.Investigation: customer returned (15) 1cc, 6mm, 31g syringes (5 loose, 10 in a sealed poly bag) from lot # 9350454.Customer states that the needles will not penetrate the insulin vial and they have to press hard on the plunger and is bruising.All returned syringes were tested (#1-5 loose, #6-15 from the sealed poly bag) for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All samples returned loose exhibited a hooked cannula point.Also, all samples were tested and all plunger rods were exercised in the barrel without any observed defects.A review of the device history record was completed for batch# 9350454.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200865632] noted that did not pertain to the complaint.Confirmed: 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 (plunger difficult to move) hooked cannula point caused during use of the product by the customer.
Event or Problem Description
It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion plunger rod was difficult to move.This was discovered during use.The following information was provided by the initial reporter: material no: 328519.Batch no: 9350454.It was reported that the needles will not penetrate the insulin vial of injection site.Consumer is also having to press hard on the plunger and is bruising.Event description per snow verbatim states: relion consumer reported, some of the needles will not penetrate the insulin vial or his injection site.Stated, he is getting bruising as a result of having to push really hard on the syringe when taking injection.Stated, does not re-use and he rotates different injection sites.Stated, has not seen a doctor.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10584349
• Report Number: 1920898-2020-01296
• Device Sequence Number: 19784929
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/13/2020

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: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9350454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other