MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2; PISTON SYRINGE

Catalog Number	305062
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 305062, batch#: 4157854.It was reported that the bd syringe blunt fill 5ml ll w/ndl 18x1-1/2 with needle coring.The following information was provided by the initial reporter: rcc received a complaint via email, chc complaint reference#: (b)(4), hospital complaint reference#: (b)(4), correspondence language: english, cat# of product being complained: bd305062, description of product: needle blunt fill 18gx1.5in w/ll 5ml syrng 100ea/bx 4bx/ca, lot or s/n: (b)(6), complaint category: foreign matter / material / dirty, reportable: no, incident date: on (b)(6) 1980, hospital complaint reference#: (b)(4).Details of complaint (reported issue): rubber stopper bit going into the vial after blunt needle is used to draw up medication.Please see the picture attached with the rubber floating in the medication from the 5ml syringe going into the vial and poking the rubber into the medication.Additional information will be sent via separate email.Incident date & sample availability unknown.Customer indicated that they wish to be provided with the final results of this investigation.Please copy 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? no, is customer requesting an rga? no.
Additional Manufacturer Narrative
One photo was provided to our quality team for investigation.The photo shows one vial with an unknown clear fluid filled halfway up with small black particulates of unknown size floating within the vial.No other information could be obtained from the photo.Based on the investigation and with the photo sample analysis the symptom reported is confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.Furthermore, a device history record review was completed for provided lot number 4157854.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2
• 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: 20321073
• Report Number: 1213809-2024-00671
• Device Sequence Number: 7862734
• Product Code: FMF
• UDI-Device Identifier: 30382903050629
• UDI-Public: (01)30382903050629(11)240605(17)290531(10)4157854
• 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): 01/15/2025

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: 305062
• Device Lot Number: 4157854
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown