MAUDE Adverse Event Report: SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305945
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a safety mechanism failure.The following information was provided by the initial reporter: no patient involvement, safety measures.
Event or Problem Description
It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a safety mechanism failure.The following information was provided by the initial reporter: no patient involvement, safety measures.
Additional Manufacturer Narrative
The following information has been added: h.6 investigation summary: since no samples (including photos) were returned for the reported issue of ¿missing or inadequate safety measures¿ with an unknown lot number regarding item # 305945 the complaint could not be confirmed, and the root cause is undetermined.A dhr check was not performed as the lot number is "unknown" for this complaint.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.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 investigation, no additional investigation and no capa is required at this time.H.6 investigation conclusion: a complaint history check was not performed as the lot number is "unknown" for this complaint.Unable to complete dhr review as the lot number was reported as unknown.As no samples and/or photo(s) were 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.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time h3 other text : see h10.

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• MDR Report Key: 12340418
• Report Number: 1920898-2021-00911
• Device Sequence Number: 4535723
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: Other
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1