MAUDE Adverse Event Report: BAUSCH + LOMB GTI CANNULA (AMAR)+23G PRE-HOLE NEEDLE; INTRADERMAL CANNULA AND NEEDLE

Model Number AJ1852A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The product has been requested, and has not yet been returned.The investigation is ongoing.

Event Description

The user facility in the (b)(6) reported during a procedure of placing dermal filler in the marionette region the cannula broke under the skin.At the end of the procedure when the filler was placed and retroactively while removing the syringe there was no cannula.The cannula could not be felt, located, or pushed up toward the entry point.It seemed to disappear in the subcutaneous or muscle in patient.The patient was taken in the hospital to stay for whole day.At no point was the cannula pushed hard it was nicely gliding under the skin in subcutaneous tissue.The position was changed and the cannula was taken all the way out, then made another path for the cannula.

Manufacturer Narrative

Vendor evaluation results: upon review of our complaints database for the last three years we have uncovered a trend of reported complaints where the needle may have potentially detached from the hub.Upon receipt of the samples provided we have performed pull testing on the x2 samples.One of the samples tested was found to be within specification.The second tested sample was found to be below specification.This indicates the potential for the destructive testing to have missed the intermittent fault within this batch.We believe the investigation we have conducted gives us good evidence that our curing process is likely to be the root cause of the issue and have taken action to prevent the issue currently, but we are also implementing a further preventative action.Our uv cure process has been re-engineered to reduce the possibility of failure.This will reduce the chance of failures from human error and will also eliminate the root cause of the issue.

Manufacturer Narrative

Additional information: d4 expiration date.H4 device manufacture date.

• Brand Name: GTI CANNULA (AMAR)+23G PRE-HOLE NEEDLE
• Type of Device: INTRADERMAL CANNULA AND NEEDLE
• Manufacturer (Section D): BAUSCH + LOMB; 26 thornhill road; north moons moat; rochester NY 14609
• Manufacturer (Section G): STERIMEDIX LIMITED; 26 thornhill road; north moons moat; redditch B98 9 ND; UK B98 9ND
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122
• MDR Report Key: 12853772
• MDR Text Key: 281094722
• Report Number: 0001920664-2021-00154
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: AJ1852A
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2019
• 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
• Patient Outcome(s): Other