MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE; PISTON SYRINGE

Catalog Number	309659
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ slip-tip disposable tuberculin syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter: during use, product was found to have discolored material on barrel of syringe, at first mistaken for contaminant/particular inside of barrel/solution, but upon disassembly the material of the barrel itself presents with dark brown spots/flecks.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 01aug2023.H6: investigation summary.One loose sample was provided to our quality team for investigation.A visual inspection was performed, and the several specks of brown embedded foreign matter were observed approximately halfway up the neck of the barrel in the print area.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.This type of defect is cosmetic and does not pose risk to the customer.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) and corrective action determination could not be performed.
Event or Problem Description
It was reported that the bd¿ slip-tip disposable tuberculin syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter: during use, product was found to have discolored material on barrel of syringe, at first mistaken for contaminant/particular inside of barrel/solution, but upon disassembly the material of the barrel itself presents with dark brown spots/flecks.

• Brand Name: BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17281207
• Report Number: 1213809-2023-00705
• Device Sequence Number: 3567191
• Product Code: FMF
• UDI-Device Identifier: 00382903096596
• UDI-Public: 00382903096596
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: Other
• Device Catalogue Number: 309659
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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