MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Model Number	305500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples (including photos) were returned for the reported issue of ¿needle separated from the syringe¿, with lot # unknown regarding ithe complaint could not be confirmed, and the root cause is undetermined.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.A dhr check was not performed as the lot number is "unknown" for this complaint.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.Based on the above, no additional investigation and no capa/sa is required at this time.
Event or Problem Description
It was reported syringe allergy 1ml w/ndl 28x1/2 rb had a needle separation issue.The following information was provided by the initial reporter: "bd allergy syringes.Needle separated from the syringe, causing him to lose the medication.".

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12523088
• Report Number: 1920898-2021-01014
• Device Sequence Number: 19910004
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 305500
• Device Catalogue Number: 305500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1