MAUDE Adverse Event Report: AVID MEDICAL, INC. OBSTETRICAL KIT

Model Number RDLD016-07

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Avid complaint number (b)(4).Avid medical is the manufacturer of the kit that contains the hemostat component manufactured by fine surgical instruments.The hospital reported "the hemostat (from the kit) broke while cutting the patient umbilical cord." no injury was reported to either patient or health care personnel.No medical intervention was needed to prevent harm.

Manufacturer Narrative

The product involved in the report is not available for evaluation.Upon completion of the investigation; a follow-up report will be filed.Avid medical is convenience kit manufacturer.The complaint component is fine surgical instruments part number mam-795-l&d.A supplier corrective action request was issued to the component manufacturer on 12/15/23.Although no sample was available or returned, a photo was provided.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.H3 other text : device not returned.

Manufacturer Narrative

The product involved in the report is not available for evaluation.A supplier corrective action request was submitted to the complaint component (b)(4) instrument set) manufacturer, fine surgical.Avid medical did not have inventory of the same component complaint lot available for inspection at the time of complaint receipt.Alternate lot samples were evaluated with no issues identified.Avid medical will continue to perform track and trending to determine if additional corrective actions are warranted.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.

• Brand Name: OBSTETRICAL KIT
• Type of Device: OBSTETRICAL KIT
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 18480704
• MDR Text Key: 332997592
• Report Number: 1047429-2024-00001
• Device Sequence Number: 1
• Product Code: OKV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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: Health Professional
• Device Model Number: RDLD016-07
• Device Catalogue Number: RDLD016-07
• Device Lot Number: 1565568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/29/2024
• 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