MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 324901

Device Problem Inaccurate Information (4051)

Patient Problem Hypoglycemia (1912)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: customer returned (1) loose 1/2cc, 6mm syringe.Customer states that very first scale mark (zero point) is marked the way too lower than it should be.The returned syringe was tested using the plug gauge and the placement of the 5 unit marking fell out of specifications.Sample will be forwarded to manufacturing (holdrege) for further review.Unable to perform dhr check for scale misaligned due to unknown lot number.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.On 15th mar 2022, holdrege received (1) loose 0.5ml syringe from unknown batch.Once received, the sample was tested per (b)(4) using plug gauge 10301.The 5 unit line fell outside of the recessed area of the gauge which means that they scale location is questionable.Per (b)(4), if accuracy of scale location is questionable, volumetric testing is to be performed.Process summary: blank barrels are transferred from totes to a bulk hopper, the hopper then meters them into the vibratory feeder, which orients and transfers the barrels single file into the first inline feeder.The first inline feeder rail transfers to the inspection dial where short molding defects are rejected.After the inspection dial, the barrels are transferred to the second inline feeder and transitions through the corona treater terminating at the inhibit gate.At cycle start, the inhibit gate opens, introducing barrels to printer infeed dial on through the flange guide which aligns the flanges for proper registration and into the print carousel where ink images are applied.From the print carousel, the barrels are transitioned to the transfer dial and into the curing oven.The cured product exits the oven chute for transfer to the next operation.Root-cause cannot be determined due to lack of batch number information.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the scale markings on 140 bd ultra-fine¿ insulin syringes were lower down the barrel than normal.The following information was provided by the initial reporter: "the very first scale mark is lower than it should be.".

• Brand Name: BD ULTRA-FINE¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13957273
• MDR Text Key: 288369438
• Report Number: 1920898-2022-00198
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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