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

Model Number	300866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd¿ eccentric luer slip tip syringe ce mark sterile had a damaged tip.The following information was provided by the initial reporter: "broken barrel".
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
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/20/2022.H.6.Investigation: sample and photo received for investigation.Upon visual inspection, the tip appears damaged and deformed.A device history review was performed for lot 2105010 no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Possible root cause is associated with transport of the barrel from molding to assembly machine.
Event or Problem Description
It was reported that bd¿ eccentric luer slip tip syringe ce mark sterile had a damaged tip.The following information was provided by the initial reporter: "broken barrel.".

• Brand Name: 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: 13319658
• Report Number: 3003152976-2022-00010
• Device Sequence Number: 1648393
• 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): 02/25/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/14/2022
• 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