MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928856
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9308766.Medical device expiration date: 2024-11-30.Device manufacture date: 2019-11-04.Medical device lot #: 9301909.Medical device expiration date: 2024-11-30.Device manufacture date: 2019-10-28.(b)(4).
Event or Problem Description
It was reported that an unspecified number of syringes 1.0ml 31ga 8mm 10bag 500 pl/wg experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no:928856, batch no: 9308766 and 9301909.Consumer reported foreign matter white mucus around the needle from this current box and prior unknown box same size.Consumer reported moisture inside barrel of syringe from this current box and prior unknown box same size.Date of event: unknown.
Event or Problem Description
It was reported that an unspecified number of syringes 1.0ml 31ga 8mm 10bag 500 pl/wg experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no:928856 batch no: 9308766 and 9301909.Consumer reported foreign matter white mucus around the needle from this current box and prior unknown box same size consumer reported moisture inside barrel of syringe from this current box and prior unknown box same size date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: unknown d.4.Medical device expiration date: unknown d.10 device available for eval yes, d.10 returned to manufacturer on: h.4.Device manufacture date: unknown h.6.Investigation summary customer returned (1) loose 1cc syringe from an unknown lot number and (10) 1cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 9308766.No samples were returned from lot # 9301909.Customer states that there is white mucus around the needle and moisture inside the barrel of the syringe.All of the returned syringes were examined and no foreign matter was observed in or on any of the samples in the sealed poly bag.However, the loose sample exhibited some foreign material on the cannula.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 uncured adhesive mixed with silicone.A review of the device history record was completed for batch# 9308766.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200858486, 200857791] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 9301909.All inspections were performed per the applicable operations qc specifications.There were four (4) notifications [200856726, 200857227, 200857278, 200856828] noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (for unknown lot number) bd was not able to duplicate or confirm the customer¿s indicated failure (for lot # 9308766 and lot # 9301909) reviews of the dhr, quality notifications, or maintenance dispatches were not possible as the batch number is unknown.Root cause cannot be determined.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 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: 10497785
• Report Number: 1920898-2020-01164
• Device Sequence Number: 3055484
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/16/2020

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: Other
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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