MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE

Catalog Number	305789
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: fmi; fmf.Pma / 510(k)#: k941562; k161170.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 a scale marking issue occurred before use with a syringe 1ml ll w/ndl eclipse 27x1/2 rb.The following information was provided by the initial reporter, "scale missing.".
Event or Problem Description
It was reported that a scale marking issue occurred before use with a syringe 1ml ll w/ndl eclipse 27x1/2 rb.The following information was provided by the initial reporter, "scale missing".
Additional Manufacturer Narrative
Investigation: dhr was performed and was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.One photo and one 1ml syringe with an eclipse needle assembly in an opened blister pack from batch 8052070 (p/n (b)(4)) was received and evaluated.It was observed there was multiple scratches and indentations on and below the flange.There was also a scratch near the bottom above the collar.It was also observed the scale on the syringe was severely skewed and smeared to the point it was almost completely illegible and was rejectable per product specification.Potential root cause for the skewed scale defect is associated with the printing process.This was most likely from the print pad being in the wrong position causing the print to be applied at an angle.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8861640
• Report Number: 8041187-2019-00608
• Device Sequence Number: 16967771
• Product Code: FMI
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 305789
• Device Lot Number: 8052070
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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