MAUDE Adverse Event Report: SYRINGE 3ML LL 200 S/C; PISTON SYRINGE

Model Number 309657

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1104797, medical device expiration date: 2026-04-30, device manufacture date: 2021-06-01.Medical device lot #: 1063213, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-04.Medical device lot #: 1043500, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-30.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.The customer's address is unknown.(b)(6) usa has been used.

Event Description

It was reported that 6 syringe 3ml ll 200 s/c had incorrect label information.The following information was provided by the initial reporter: "it was reported by the medical professional, the boxes have different packaging and they are two different sizes with the same reference number.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported that 6 syringe 3ml ll 200 s/c had incorrect label information.The following information was provided by the initial reporter: " it was reported by the medical professional, the boxes have different packaging and they are two different sizes with the same reference number.".

• Brand Name: SYRINGE 3ML LL 200 S/C
• Type of Device: PISTON SYRINGE
• MDR Report Key: 12475556
• MDR Text Key: 271511775
• Report Number: 1213809-2021-00637
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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
• Device Operator: Other
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1