MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD SAFETY-LOK¿ TUBERCULIN SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305553
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the 1 ml bd safety-lok¿ tuberculin syringe with 27 g x 1/2 in.Permanently attached needle had scale marking issues and appeared to had crooked markings.Found during use.No serious injury or medical interventions noted.
Additional Manufacturer Narrative
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 check was not performed as the lot number is "unknown" for this complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.No additional investigation and no capa is required at this time.Level a investigation complaint evaluation / complaint history check for the event(s) that occurred.Occurrence: a complaint history check was not performed as the lot number is "unknown" for this complaint.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 check was not performed as the lot number is "unknown" for this complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

• Brand Name: 1 ML BD SAFETY-LOK¿ TUBERCULIN SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7060057
• Report Number: 1920898-2017-00316
• Device Sequence Number: 1378572
• Product Code: FMI
• UDI-Device Identifier: 00382903055531
• UDI-Public: 00382903055531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: Other
• Device Catalogue Number: 305553
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/21/2017
• 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