MAUDE Adverse Event Report: COVIDIEN 101 S-RX TB SP BULK; SYRINGE, PISTON

Model Number 8881101011

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Retinal Injury (2048)

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the syringe caused a hole in the retina.Additional information was provided on 13-jan-2021 stating that the patient was undergoing a vitrectomy and when the doctor was injecting balanced salt solution (bss) with the tuberculosis (tb) syringe it was difficult to press the plunger requiring force which caused a hole in the patient¿s retina.Additional information received on 26-jan-2021 stated that the patient did not require treatment above or beyond what occurred in the originally scheduled procedure.She further stated that the her best estimate is that the incident occurred between (b)(6) 2020.Patient's current status: no adverse outcomes were reported from the scheduled procedure.

Manufacturer Narrative

Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for the investigation.Five (5) pictures were received for the analysis.Upon visual examination, the reported issue is not confirmed.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Per manufacturing site procedure, complaint trends are evaluated during the monthly corrective and preventive action (capa) meeting to determine if a capa is warranted.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 101 S-RX TB SP BULK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11247900
• MDR Text Key: 229304720
• Report Number: 1915484-2021-01203
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881101011
• Device Catalogue Number: 8881101011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Patient Sequence Number: 1