MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA FINE INSULIN SYRINGE; PISTON SYRINGE

Model Number	329416
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	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 130 bd ultra fine¿ insulin syringe experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no:329416 batch no: unknown.Reported on behalf of consumer that the consumer had approximately 130 insulin syringes with condensation inside of the barrel and poly bags.Stated when the consumer draws up the insulin there is a small line in the barrel that moves it, believing it is condensation.Unable to provide lot #.Date of event: unknown.
Additional Manufacturer Narrative
H6.Investigation summary: no samples (including photos) were returned as of 31 july 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review for foreign matter in barrel and foreign matter in polybag due to unknown lot number.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.H3 other text : see h10.
Event or Problem Description
It was reported that 130 bd ultra fine¿ insulin syringe experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no:329416 batch no: unknown.Reported on behalf of consumer that the consumer had approximately 130 insulin syringes with condensation inside of the barrel and poly bags.Stated when the consumer draws up the insulin there is a small line in the barrel that moves it, believing it is condensation.Unable to provide lot #.Date of event: unknown.

• Brand Name: BD ULTRA FINE INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10277267
• Report Number: 1920898-2020-00859
• Device Sequence Number: 11386796
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (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): 07/31/2020

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 Model Number: 329416
• Device Catalogue Number: 329416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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