MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB; PISTON SYRINGE

Model Number	305537
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe allergy 1ml w/ndl 26x1/2 rb leaked.The following information was provided by the initial reporter: "it was reported that the syringes were leaking when drawing up fluid.Event description per attached email states: item: 305537, quantity affected: 1 case, serial/lot number: na.Are any samples available for return? yes reported issue: syringes were leaking when they tried drawing fluid.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A dhr was not performed as the lot number is "unknown" for this complaint.
Event or Problem Description
It was reported that syringe allergy 1ml w/ndl 26x1/2 rb leaked.The following information was provided by the initial reporter: "it was reported that the syringes were leaking when drawing up fluid.Event description per attached email states: item: 305537.Quantity affected: 1 case.Serial/lot number: na.Are any samples available for return? yes.Reported issue: syringes were leaking when they tried drawing fluid.".

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10312314
• Report Number: 1920898-2020-00922
• Device Sequence Number: 3749566
• Product Code: FMF
• UDI-Device Identifier: 30382903055372
• UDI-Public: 30382903055372
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/28/2020

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: 305537
• Device Catalogue Number: 305537
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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