MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1 RB; PISTON SYRINGE

Catalog Number	309578
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 error was found before use with syringes 3ml ll w/ndl 20x1 rb.The following information was provided by the initial reporter, "the measurement markings are off on this batch of syringes.".
Event or Problem Description
It was reported that scale marking error was found before use with syringes 3ml ll w/ndl 20x1 rb.The following information was provided by the initial reporter, "the measurement markings are off on this batch of syringes.".
Additional Manufacturer Narrative
H.6.Investigation: one photo and total of 1,757 sealed and packaged 3ml syringes, confirmed to be from batch 9072981 (b)(4),were received and evaluated.It was observed 3 of the syringes had varying degrees of skewed scale resulting in missing print in the scale markings.Two of the syringes were missing the ¿2¿ of the ¿1/2¿ ml marking.One syringe was missing all numbers below the 11/2 ml marking and the ¿1/2¿ from the ¿11/2¿ marking, making it appear as ¿1.¿ the scale marking defect observed in all 3 of the syringes was found to be rejectable per product specification.No scale marking defects were observed in 1,754 remaining syringes.Machine logs indicate marker issues were present during the manufacture of this batch.Potential root cause for the skewed scale defect is associated with equipment setup.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

• Brand Name: SYRINGE 3ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8828152
• Report Number: 1213809-2019-00766
• Device Sequence Number: 2625118
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 02/29/2024
• Device Catalogue Number: 309578
• Device Lot Number: 9072981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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