MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE; PISTON SYRINGE

Model Number	300866
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile the stopper was found to be deformed.The following information was provided by the initial reporter: distorted stopper.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile the stopper was found to be deformed.The following information was provided by the initial reporter: distorted stopper.
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile the stopper was found to be deformed.The following information was provided by the initial reporter: distorted stopper.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-01-17.H6: investigation summary sample and photos received for investigation.Upon visual inspection, the stopper assembled incorrectly is observed.No further damage can be seen.A device history review was performed for reported lot 2105010, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Possible root cause is associated when there is a misalignment of plunger-stopper-barrel in the assembly station during assembly process.In assembly stations of 50ls manufacturing lines there is a vision system to detect stoppers bad assembled or missing stopper.In case any is defective it is rejected automatically to scrap.In this case, vision system has not detected the failure, and no rejection was made.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.

• Brand Name: 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13337830
• Report Number: 3003152976-2022-00017
• Device Sequence Number: 11778311
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 04/30/2026
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2105010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown