MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Catalog Number	928853
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
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.
Event or Problem Description
It was reported that an unspecified number of syringe 1.0 ml 30 ga 8 mm 10bag 500 pl/wg experienced an inability or difficult aspirating during use.The following information was provided by the initial reporter: material no.928853, batch no.8176693.Verbatim: consumer reported that his syringe will not draw the insulin, stated that he is new to using syringes, does not re-use.Lot # 8176693, product # 928853, no exp date.
Event or Problem Description
It was reported that an unspecified number of syringe 1.0ml 30ga 8mm 10bag 500 pl/wg experienced an inability or difficult aspirating during use.The following information was provided by the initial reporter: material no.928853 batch no.8176693.Verbatim: consumer reported that his syringe will not draw the insulin, stated that he is new to using syringes, does not re-use.Lot # 8176693, product # 928853, no exp date.
Additional Manufacturer Narrative
H.6.Investigation summary: customer returned one (1) loose 30g x 8mm, 1ml walgreens insulin syringe from lot 8176693.Consumer reported that his syringe will not draw the insulin.The returned sample was examined, then tested for flow using water: the syringe was able to draw and expel water properly.As no evidence of manufacturing defects were observed, the alleged issue could not be confirmed.A review of the device history record was completed for batch# 8176693.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200768481] noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: SYRINGE 1.0ML 30GA 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: 8872025
• Report Number: 1920898-2019-00770
• Device Sequence Number: 16772788
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• 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): 08/21/2019

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: 928853
• Device Lot Number: 8176693
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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