MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 50 ML BD PLASTIPAK LUER-SLIP SYRINGE; PISTON SYRINGE

Catalog Number	300866
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter addr 1: (b)(6).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 60 50 ml bd plastipak¿ luer-slip syringes experienced scale marking issues.The following information was provided by the initial reporter: smudging of the lines and wordings.
Event or Problem Description
It was reported that 60 50 ml bd plastipak¿ luer-slip syringes experienced scale marking issues.The following information was provided by the initial reporter: smudging of the lines and wordings.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 11/25/2020 h.6.Investigation: five sealed samples of lot 2003206 for provided to our quality team for investigation.The product was visually inspected, the marking for 0ml is not completely printed on the barrel, some markings are observed to be lighter, however, the scale and markings are legible.A device history review was performed for the reported lot 2003206, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.While we could not identify a direct issue, this defect can occur due to a failure in the patters or flaming system used to transfer the ink onto the barrel.See h.10.

• Brand Name: 50 ML BD PLASTIPAK LUER-SLIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10939118
• Report Number: 3003152976-2020-00542
• Device Sequence Number: 583515
• Product Code: FMF
• UDI-Device Identifier: 00382903008667
• UDI-Public: 00382903008667
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K980987
• 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): 12/21/2020

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: 02/28/2025
• Device Catalogue Number: 300866
• Device Lot Number: 2003206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1