MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA NO INS; PISTON SYRINGE

Catalog Number	329408
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	07/25/2019
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 #: 7240986.Medical device expiration date: n/a.Device manufacture date: 2017-10-26.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of syringe 0.5 ml 31ga no ins experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 329408, batch no.: 7240986, unknown.When moving the plunger outside of vial before drawing up insulin, presses to the top the plunger and white stuff comes out of needle.The plunger rod has a rest position of 2 units.Unknown occurrence date.Found this white stuff coming out of needle on 6 other prior boxes.
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7240986.All inspections and challenges were performed per the applicable operations qc specifications.There were five (5) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for adhesive splatter.
Event or Problem Description
It was reported that an unspecified number of syringe 0.5ml 31ga no ins experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 329408 batch no.: 7240986, unknown.When moving the plunger outside of vial before drawing up insulin, presses to the top the plunger and white stuff comes out of needle.The plunger rod has a rest position of 2 units.Unknown occurrence date.Found this white stuff coming out of needle on 6 other prior boxes.

• Brand Name: SYRINGE 0.5ML 31GA NO INS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8879618
• Report Number: 1920898-2019-00790
• Device Sequence Number: 16767881
• Product Code: FMF
• UDI-Device Identifier: 00382903294084
• UDI-Public: 00382903294084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 08/26/2019

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: Lay User/Patient
• Device Catalogue Number: 329408
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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