MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SCALE MARK SYRINGE WITH LUER-LOK TIP; PISTON SYRINGE

Model Number	303390
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd scale mark syringe with luer-lok tip foreign matter was discovered.There was no report of patient impact.The following information was provided by the initial reporter: in this syringe behind the stopper was a lot of ¿powdery substance¿.She removed this from the package and drew up heparin.When she went to release the extra air she noticed all the powder.
Additional Manufacturer Narrative
H6: investigation summary: since no samples (including photos) were returned for the syringe 3ml ll 200 s/c, product code# 30965780, from lot# 2228127, with the reported issue of ¿foreign matter¿, the complaint could not be confirmed, and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch #2228127.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
Event or Problem Description
It was reported while using bd scale mark syringe with luer-lok tip foreign matter was discovered.There was no report of patient impact.The following information was provided by the initial reporter: in this syringe behind the stopper was a lot of ¿powdery substance¿.She removed this from the package and drew up heparin.When she went to release the extra air she noticed all the powder.

• Brand Name: BD SCALE MARK SYRINGE WITH LUER-LOK TIP
• 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: 16251467
• Report Number: 1920898-2023-00028
• Device Sequence Number: 17455430
• Product Code: FMF
• UDI-Device Identifier: 30382903033905
• UDI-Public: (01)30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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 Model Number: 303390
• Device Catalogue Number: 30965780
• Device Lot Number: 2228127
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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