MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928850
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	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg experienced foreign matter on device cannula/in fluid path.The following information was provided by the initial reporter: consumer reported found 1 syringe from a sealed packet with foreign red matter in syringe.Caller opened the packet herself but is very concerned.Lot # 0069025.Catalog# 928850.Date of event (b)(6) 2021.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-18.H6: investigation summary: customer returned (1) 1cc, 12.7mm, 29g walgreens syringe in an open poly bag from lot # 0069025.Customer states that 1 syringe has red foreign matter in syringe.The returned syringe was examined and exhibited dark material in the barrel.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood mixed with an unknown medication.The blood would not have been acquired inside the syringe barrel during the manufacturing process.A review of the device history record was completed for batch# 0069025.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint root cause is user related as blood would not be acquired inside the syringe barrel during the manufacturing process.
Event or Problem Description
It was reported that the syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg experienced foreign matter on device cannula/in fluid path.The following information was provided by the initial reporter: consumer reported found 1 syringe from a sealed packet with foreign red matter in syringe.Caller opened the packet herself but is very concerned.Lot # 0069025; catalog# 928850; date of event 02/05/2021.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11407657
• Report Number: 1920898-2021-00260
• Device Sequence Number: 2190932
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Model Number: 928850
• Device Catalogue Number: 928850
• Device Lot Number: 0069025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1