MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number	309570
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that while using the bd luer-lok¿ syringe was leaking.Report 2 of 2.The following was received by the initial reporter: customer reported that the patient is out of remodulin because yesterday she had issues when making the new cassette and she ended up wasting medication for 2 cassettes.She reported that when she made the first cassette, the tip of the needle broke inside and the second cassette was leaking.Both cassettes were discarded.She did not provide any lot numbers for the affected cassettes.The third cassette created yesterday was fine and that is what the patient is currently using.Patient is on subcutaneous remodulin therapy using remunity pumps.Patient's mother did not report that patient experienced any changes in breathing or side effects.No other information provided.Subcutaneous self-fill remunity pt.Pt actively on uptravi and tadalafil.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided? please explain.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.Usa has been used as a default e.4.Fda notified: the initial reporter also notified the fda via medwatch# [mw5119299].Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported by the customer that while using the bd luer-lok¿ syringe was leaking.Report 2 of 2.The following was recieved by the initial reporter: customer reported that the patient is out of remodulin because yesterday she had issues when making the new cassette and she ended up wasting medication for 2 cassettes.She reported that when she made the first cassette, the tip of the needle broke inside and the second cassette was leaking.Both cassettes were discarded.She did not provide any lot numbers for the affected cassettes.The third cassette created yesterday was fine and that is what the patient is currently using.Patient is on subcutaneous remodulin therapy using remunity pumps.Patient's mother did not report that patient experienced any changes in breathing or side effects.No other information provided.Subcutaneous self-fill remunity pt.Pt actively on uptravi and tadalafil.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided? please explain.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17466787
• Report Number: 2243072-2023-01376
• Device Sequence Number: 12558214
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: 30382903095705
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: Lay User/Patient
• Device Catalogue Number: 309570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown