MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305060
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 18x1-1/2 blunt fill barrel cracked.The following information was provided by the initial reporter: verbatim: one of our intermountain facilities is reporting an issue/concern with an item that it is purchased from your company.Situation: issue: plastipak 3ml syringe barrel cracked, blood leaking during blood draw.Background: event date: 7/15/2024.Ih #: 93021798 mfg #: 305060 description: syringe 3ml 18gax1.5 blunt fill l/l tip.Sample available: no sample or photos are available for this event.Lot #: 4031508 assessment: credit requested no was there injury? no name of facility : main contact name and phone number: self.Frontline caregivers contact information (if applicable): na account # po purchased on: (b)(4).Recommendation/request: there is no sample or photo available for this event, reporting purpose only.
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) was used.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.

• Brand Name: BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL
• 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: 19959643
• Report Number: 1213809-2024-00522
• Device Sequence Number: 12528819
• Product Code: FMF
• UDI-Device Identifier: 30382903050605
• UDI-Public: (01)30382903050605
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 07/19/2024

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: 305060
• Device Lot Number: 4031508
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown