MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/TWINPAK DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303391
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a quality notification was issued for a jam resulting in missing print.Adjustments were made and batch 0328464 was inspected and accepted based on meeting our inspection control plan.Since no samples displaying the reported condition were received a potential root cause could not be defined.It is possible that a jam caused some barrels to be damaged, however without samples it is not possible to make that determination.Since root cause could not be defined, corrective actions are not necessary.
Event or Problem Description
It was reported that 3 syringe 3ml ll w/twinpak device were found to be damaged.The following was reported by the initial reporter: "it was reported that 3 syringes were cracked on the side.Per complaint details received: having an issue with 3 syringes cracked on side during a radiology procedure, 3 times our di staff have had 3 different syringes break: ref # (b)(4), this has been reported to healthtrust in the gpo member support portal.".

• Brand Name: SYRINGE 3ML LL W/TWINPAK DEVICE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11847801
• Report Number: 1213809-2021-00337
• Device Sequence Number: 3747390
• Product Code: FMI
• UDI-Device Identifier: 30382903033912
• UDI-Public: 30382903033912
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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 Expiration Date: 11/30/2025
• Device Model Number: 303391
• Device Catalogue Number: 303391
• Device Lot Number: 0328464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1