MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK; 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	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other possible lot number includes 3264104 and other possible expiration date includes 2028-09-30.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other possible lot number device manufacture date is 2023-11-29.
Event or Problem Description
Material#: 309604 , batch#:(b)(6).It was reported that the bd luer-lok syringe barrel cracked.The following information was provided by the initial reporter translated from french to english: rcc received a complaint via email.Lot or s/n: (b)(6), complaint category: fail to function / defective, reportable: no, incident date: on (b)(6) 2024, hospital complaint reference #: (b)(4).Details of complaint (reported issue): issue: interior of the barrel cracked.Per customer: interior of the barrel cracked which, during the infusion of the medication (tobramycin on a syringe pump), caused the medication to flow back behind the plunger of the syringe.The nurse noticed the loss when rinsing because a quantity of medicine leaked onto her hands.The infusion was programmed for 6.7ml at a rate of 13.4ml/h.It is impossible to estimate the quantity of medication lost.The crack is internal and does not seem to extend to the outside of the barrel.Impact of the problem: the patient therefore did not receive a full dose as planned.(antibiotic underdose) an ah 223 declaration was produced under (b)(6).French customer indicated that they wish to be provided with the final results of this investigation.Please (b)(6) when sending to the customer.** complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no has health canada been informed? unknown qty affected: 1 ea samples available? yes is customer requesting an rga?: no return qty: qty samples: 1 ea additional information provided: 1.Has an adverse event or serious injury been reported to the patient or healthcare professional? if yes, please provide details.No adverse events to either the patient or the staff.2.For both batches, the event date is the same? the batch number is uncertain but we had on hand the 2 batch numbers mentioned on the form.Only one incident occurred.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information.

• Brand Name: BD LUER-LOK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19755828
• Report Number: 9614033-2024-00050
• Device Sequence Number: 15104737
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: (01)30382903096047
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: Health Professional
• Device Catalogue Number: 309604
• Device Lot Number: 3264106
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown