MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305540
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
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.(b)(4).
Event or Problem Description
It was reported that scale markings were discovered to be missing prior to use with a bd syringe allergy 1ml w/ndl 27x1/2 rb.The following information was provided by the initial reporter: it was reported that there was one case of syringes that were labeled incorrectly.Pictures received show that the scale markings are missing.
Event or Problem Description
It was reported that scale markings were discovered to be missing prior to use with a bd syringe allergy 1ml w/ndl 27x1/2 rb.The following information was provided by the initial reporter: it was reported that there was one case of syringes that were labeled incorrectly.Pictures received show that the scale markings are missing.
Additional Manufacturer Narrative
Investigation summary customer returned photos of 1cc bd allergy syringes.Customer states that one case had syringes that were not labeled correctly or completely.The photo was examined and exhibited missing scale markings below the 0.6 ml marking.A review of the device history record was completed for batch # 9234695.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to confirm the customer¿s indicated failure.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.There were no quality notifications or maintenance dispatches during the production of this batch that pertained to this complaint.Root cause cannot be determined.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10446153
• Report Number: 1920898-2020-01108
• Device Sequence Number: 16881351
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: 30382903055402
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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 Expiration Date: 08/31/2024
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 9234695
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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