MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328519
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0223926, medical device expiration date: na, device manufacture date: 2020-08-10.Medical device lot #: 0099968, medical device expiration date: na, device manufacture date: 2020-06-22.Medical device lot #: 0217457, medical device expiration date: na, device manufacture date: 2020-08-04.Medical device lot #: 0006079, medical device expiration date: na, device manufacture date: 2020-02-26.Medical device lot #: 0090421, medical device expiration date: na, device manufacture date: 2020-05-01.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 it was difficult to measure 5 units of insulin with relion® insulin syringe scales 1 ml markings.This occurred with syringes in lots 0223926, 0099968, 0217457, 0006079, and 0090421.The following information was provided by the initial reporter: "pet owner stated her dog takes 5 units of insulin and the current syringes are in increments of 10 which she can not use.Stated it is hard to measure 5 units with the 1 ml syringes.Stated she purchased 10 boxes and did not realize how the scale markings are with the 1ml syringes.Stated her pet was previously using the 3/10 ml, 6mm syringes.".
Event or Problem Description
It was reported that it was difficult to measure 5 units of insulin with relion® insulin syringe scales 1 ml markings.This occurred with syringes in lots 0223926, 0099968, 0217457, 0006079, and 0090421.The following information was provided by the initial reporter: "pet owner stated her dog takes 5 units of insulin and the current syringes are in increments of 10 which she can not use.Stated it is hard to meausure 5 units with the 1 ml syringes.Stated she purchased 10 boxes and did not realize how the scale markings are with the 1ml syringes.Stated her pet was previously using the 3/10 ml, 6mm syringes.".
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 0090421.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200879331] noted for missing scale lines.There was one (1) notification [200865384] noted for missing print a review of the device history record was completed for batch# 0006079.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200867228] noted for scratch print.There was one (1) notification [200867227] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 0217457.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200899863] noted for damaged barrel.A review of the device history record was completed for batch# 0099968.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200867228] noted for scratch print.There was one (1) notification [200888551] noted for missing zero line.There was one (1) notification [200865384] noted for missing print.There was one (1) notification [200867227] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 0223926.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200867228] noted for scratch print.There was one (1) notification [200867227] noted that did not pertain to the complaint.H3 other text : see h10.

• Brand Name: RELION INSULIN SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11052173
• Report Number: 1920898-2020-01727
• Device Sequence Number: 2684241
• Product Code: FMI
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1