MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML E/T; SYRINGE, PISTON

Catalog Number	300613
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	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"had a 20ml bd plastipak syringe with 600mg teicoplanin in it.Noticed at towards the very end of administration (teicoplanin having been dissolved in 15ml water for injections) that a tiny free fragment of what looked like the syringe black rubber plunger component was floating in the solution.I am confident that no such fragment had been injected into the patient as i observed throughout.I did not inject this final portion of fluid but instead discarded it onto a clean paper towel and the fragment (tiny) was just visible.Unfortunately the (wrapper) serial number of the syringe had been discarded and was irretrievable but best guess based on other adjacent syringes in the drawer is : (b)(4); manuf 2023-03-01; exp 2028 -02-29; lot: 2303021.".
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2303021, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Retained samples from the same lot were used for additional evaluation.All product was inspected and no defects or foreign matter was observed on any of the devices.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 20ML E/T
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18967450
• Report Number: 3003152976-2024-00190
• Device Sequence Number: 20534885
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: (01)30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 300613
• Device Lot Number: 2303021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown