MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 27X3/8 RB; PISTON SYRINGE

Model Number	305542
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.: 305542.Batch no.: 9064874.It was reported that before use of the syringe allergy 1ml w/ndl 27x3/8 rb the syringe there was an issue with foreign matter.The syringe looked and smelled dirty.The following information was provided by the initial reporter: the label and syringe that looks and smells dirty.We know it was sterile, but it still seems ¿yucky.¿ with the label you have the lot#, and the item#, and you can see the filth on the barrel of the syringe.
Additional Manufacturer Narrative
Investigation: customer returned a photo of a 1ml, 10mm, 27g bd allergy syringe and tray from lot # 9064874.Customer states that the syringe looked and smelled dirty.The attached photo was examined and exhibited reddish material on the plunger rod.Without the actual sample, it is difficult to determine the identity of this material and any possible root cause.A review of the device history record was completed for batch # 9064874.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
Material no.: 305542 batch no.: 9064874.It was reported that before use of the syringe allergy 1ml w/ndl 27x3/8 rb the syringe there was an issue with foreign matter.The syringe looked and smelled dirty.The following information was provided by the initial reporter: the label and syringe that looks and smells dirty.We know it was sterile, but it still seems ¿yucky¿.With the label you have the lot#, and the item#, and you can see the filth on the barrel of the syringe.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 27X3/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9440401
• Report Number: 1920898-2019-01400
• Device Sequence Number: 14046233
• Product Code: FMF
• UDI-Device Identifier: 30382903055426
• UDI-Public: 30382903055426
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (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): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 305542
• Device Catalogue Number: 305542
• Device Lot Number: 9064874
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other