MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD TUBERCULIN SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	305620
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	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue occurred on several occasions, however, only (b)(6) 2022 was provided.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1263485, medical device expiration date: 31-dec-2026, device manufacture date: 20-sep-2021.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that there is foreign matter on bd tuberculin syringe with permanently attached needle.This occurred several times, however, no patient impact reported.The following information was provided by the initial reporter: this customer called in to advise that the syringes have foam at the tip, asking if this is normal.They say this has happened numerous times.
Additional Manufacturer Narrative
H6: investigation summary: customer returned an image of a 1/2cc syringe.Customer states that there is foreign matter on the syringes.The photo was examined and exhibited a stringy, black piece of material on the cannula.It is difficult to determine the identity of this material solely from the photo.A review of the device history record was completed for batch #1263485.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Embecta was able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as it is difficult to determine the identity of this material solely from the photo.
Event or Problem Description
It was reported that there is foreign matter on bd tuberculin syringe with permanently attached needle.This occurred several times, however, no patient impact reported.The following information was provided by the initial reporter: this customer called in to advise that the syringes have foam at the tip, asking if this is normal.They say this has happened numerous times.

• Brand Name: BD TUBERCULIN SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15104150
• Report Number: 1920898-2022-00484
• Device Sequence Number: 20193176
• Product Code: FMF
• UDI-Device Identifier: 00382903056200
• UDI-Public: 00382903056200
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 305620
• Device Lot Number: SEE H10
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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