MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL BNS; PISTON SYRINGE

Catalog Number	304134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: as no physical sample or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material: 304134, batch#: unknown.It was reported that the bd syringe control 10ml ll bns had tip breakage.The following information was provided by the initial reporter: rcc received a complaint via email.Medline complaint#: (b)(4), defect description: syringe broke, medline part#: 23119, product description: syr cntrl 10ml l/lit was reported that the bd syringe control 10ml ll bns tip broke.The following information was provided by the initial reporter: vendor part#: 304134, lot#: unknown, date reported: 10/11/2024, sample received: no, response needed: summary of findings and corrective action -- incident reported to the fda as mdr-30 day.Reference no.1423395-2024-00494.Additional information provided: 1.Kindly provide the batch/lot number of the product.Unknown.2.Kindly provide the date of event.10/11/2024.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No medical intervention or injury.4.Please provide the address of the facility for us to ship the return label? sample is not available; was not returned.5.Could you please provide a further description of the issue? the adapter tip is breaking off of the syringe and the plunger is off center and comes out.

• Brand Name: BD SYRINGE CONTROL 10ML LL BNS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20853005
• Report Number: 1213809-2024-00920
• Device Sequence Number: 8100303
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: 304134
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown