MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 20 ml bd¿ eccentric luer slip tip syringe ce mark there was a crack.There was no report of patient impact.The following information was provided by the initial reporter: product complaint.Syringe had a crack on the barrel.Occurrence customer has product to return.Please send customer a return kit for product investigation.Lot# 2111059.Sap search (2 possible mat # 300613(pr# (b)(4)) or 309657 (pr# (b)(4).
Additional Manufacturer Narrative
Pr 8942761 - follow up mdr for device evaluation.It was reported there was a crack on the barrel of the syringe.As a sample was not returned, a thorough sample evaluation could not be performed.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided material number 309657, lot 2111059.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lot 2111059 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received corrective actions are not necessary.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10 manufacture narrative.
Event or Problem Description
No additional information.

• Brand Name: 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17873701
• Report Number: 3002682307-2023-00302
• Device Sequence Number: 15247126
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• 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): 02/13/2024

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 Catalogue Number: 300613
• Device Lot Number: 2111059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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