MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Catalog Number	928850
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that scale marking issue occurred during use with a syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg.The following information was provided by the initial reporter, "consumer states scale markings are not proper.States the 0 line is about 1 unit above the final rest place of the top of the stopper.".
Additional Manufacturer Narrative
Investigation summary: customer returned one (1) loose 29g x 12.7mm, 1ml insulin syringe.Consumer states scale markings are not proper; states the 0 line is about 1 unit above the final rest place of the top of the stopper.The returned syringe was examined, then tested using a 1ml syringe plug gauge: the sample did not fall within the plug gauge specification.A review of the device history record was completed for batch # 8142691.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200762423] noted for missing print as per investigation completed by manufacturing, "on 26nov2019, holdrege received (1) 1.0ml, 29g, 1/2in syringe from lot #8142691.The sample was decontaminated per hstr-17 and hqa-68 prior to being evaluated.Visual inspection of the syringe found the zero line further away from the barrel tip.The syringe was tested per tp700264 using plug gauge 10116.The "10" unit scale line did not fall within the recessed area of the plug gauge.Per qc700450, if accuracy of scale location is questionable, volumetric testing is to be performed.The syringe had volumetric testing performed per tp700119.Volumes are measured at the 40 and 100 scale lines.Per the chart in section 6.5 of qc700450, the spec range at the 40 is 0.3761-0.4220g, and the spec range at the 100 is 0.9478-1.0476g.The syringe passed volumetric testing using calibrated scale, id# 13839, and is within volumetric specification.The volume at 40 unit line was 0.3997g.The volume at the 100 unit line was 0.9947g.The volumetric results ensure that dosing is accurate.".
Event or Problem Description
It was reported that scale marking issue occurred during use with a syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg.The following information was provided by the initial reporter, "consumer states scale markings are not proper.States the 0 line is about 1 unit above the final rest place of the top of the stopper.".

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9377750
• Report Number: 1920898-2019-01341
• Device Sequence Number: 19734056
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 928850
• Device Lot Number: 8142691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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