MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number	309604
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok¿ tip syringe barrel was cracked when removing it from the packaging.The following information was provided by the initial reporter, translated from japanese: "the customer reported that the barrel was cracked when opened.Potential lot number:23al100, 23a2400, 23b0700".
Additional Manufacturer Narrative
D.4.The reported lot#s 23al100, 23a2400, 23b0700 were not found for the reported catalog# 309604.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: sample and photos received by our quality team for investigation.Through visual evaluation, cracked barrel is observed.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the teams investigation, possible root cause is associated with jamming in conveyor belts.Verification and adjustments will be implemented.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.
Event or Problem Description
It was reported that the bd luer-lok¿ tip syringe barrel was cracked when removing it from the packaging.The following information was provided by the initial reporter, translated from japanese: "the customer reported that the barrel was cracked when opened.Potential lot number:23al100, 23a2400, 23b0700".
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report 9614033-2023-00095 was sent in error.Damaged / deformed product - device is operable (associated defect could occur during use.Ie¿cracked syringe) is not considered to be a reportable malfunction.Mfr#: 9614033-2023-00095 is void as a result.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17715751
• Report Number: 9614033-2023-00095
• Device Sequence Number: 20512528
• Product Code: FMF
• UDI-Device Identifier: 00382903096046
• UDI-Public: 00382903096046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151766
• 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): 09/14/2023

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: 309604
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 08/27/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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